Drugs / Erenumab
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed migraine disorder 3 milestones | |||||
| Filed | EU (EMA) | Aimovig | migraine disorder | 2018-04-17 | “AMG 334 (erenumab) became the first anti-CGRP monoclonal antibody to be submitted to both FDA and EMA for migraine prevention.” novartis.com ↗ “the European Medicines Agency has validated the Marketing Authorization Application (MAA) for Aimovig.” amgen.com ↗ |
| Filed | US (FDA) | Aimovig | migraine disorder | 2017-05-18 | “In June, the Company submitted a supplemental Biologics License Application (BLA) to the FDA for the 140 mg Sureclick ® autoinjector device and 140 mg prefilled syringe.” amgen.com ↗ “today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration ( FDA ) for erenumab to prevent migraine.” amgen.com ↗ “Regulatory submissions for Aimovig have been filed in the United States (U.S.) and Europe .” amgen.com ↗ “Aimovig (Biologics License Application submitted to FDA in May 2017 )” amgen.com ↗ “erenumab (Biologics License Application submitted to FDA in May 2017)” novartis.com ↗ |
| Filed | Japan (PMDA) | Aimovig | migraine disorder | — | “In September, a marketing authorization application was filed with the Japan Pharmaceuticals and Medical Devices Agency for Aimovig for the prevention of migraine.” amgen.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | AIMOVIG | — | 2019-03-11 – 2022-10-03 | fda.gov ↗ |
| Approved | EU (EMA) | Aimovig | — | 2018-07-26 | europa.eu ↗ |
| Approved | US (FDA) | AIMOVIG | — | 2018-05-17 | fda.gov ↗ |
Trials 48
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials · 1 met primary · 1 missed | ||||||
| Phase 1 | NCT04920331 | Sep 2021 → Feb 2022 | migraine disorder | Mayo Clinic | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04179474 | Sep → Dec 2019 | migraine disorder | Allergan | Completed | No outcome recorded |
| Phase 1 | NCT03499119 | May 2018 → Nov 2021 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02741310 | Feb → Aug 2016 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02792517 | Feb → Sep 2016 | migraine disorder | Amgen | Completed | Met primary |
| Phase 1 | NCT02542605 | Nov 2015 → Sep 2017 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01890109 | May 2013 → Mar 2014 | — | Amgen | Completed | Missed primary |
| Phase 1 | NCT01723514 | Nov 2012 → Jul 2014 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01688739 | Mar 2012 → Mar 2013 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 212 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT05684692 | Aug 2023 → Nov 2026 expected | chronic pain syndrome, schwannomatosis | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05049057 | Jul 2022 → May 2026 overdue | traumatic brain injury, traumatic encephalopathy | Henry M. Jackson Foundation for the Advancement of Military Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT04970355 | Dec 2021 → Sep 2023 | cluster headache syndrome | Charite University, Berlin, Germany | Completed | Missed primary |
| Phase 2 | NCT04303845 | Aug 2021 → Apr 2022 | hemicrania continua | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04098250 | Jan 2021 → Jan 2024 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT04419259 | Jun 2020 → Mar 2021 | rosacea | Messoud Ashina | Unknown | No outcome recorded |
| Phase 2 | NCT03974360 | Apr → Dec 2019 | traumatic brain injury, traumatic encephalopathy | Danish Headache Center | Completed | No outcome recorded |
| Phase 2 | NCT02630459 | Jan 2016 → Sep 2017 | migraine disorder | Amgen | Completed | Mixed |
| Phase 2 | NCT02575833 | Nov 2015 → Jan 2017 | coronary artery disorder | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT02174861 | Jun 2014 → May 2017 | — | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT02066415 | Mar 2014 → Feb 2016 | — | Amgen | Completed | Met primary |
| Phase 2 | NCT01952574 | Aug 2013 → Sep 2014 | migraine disorder | Amgen | Completed | Met primary |
| Phase 310 trials · 6 met primary | ||||||
| Phase 3 | NCT06411067 | Feb 2020 → May 2022 | fibromyalgia | United States Naval Medical Center, Portsmouth | Withdrawn | No outcome recorded |
| Phase 3 | NCT04114630 | Oct 2019 → Dec 2021 | migraine disorder | Novartis Pharmaceuticals | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03832998 | Sep 2019 → Jan 2025 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT03867201 | Aug 2019 → Aug 2021 | migraine disorder | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03836040 | Jul 2019 → Nov 2025 overdue | migraine disorder | Amgen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03812224 | Apr 2019 → Mar 2020 | migraine disorder | Amgen | Completed | Met primary |
| Phase 3 | NCT03333109 | Feb 2018 → Jan 2020 | migraine disorder | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03096834 | Mar 2017 → Jan 2018 | migraine disorder | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02483585 | Jul 2015 → Jul 2016 | migraine disorder | Amgen | Completed | Met primary |
| Phase 3 | NCT02456740 | Jul 2015 → Sep 2016 | migraine disorder | Amgen | Completed | Met primary |
| Phase 415 trials · 4 met primary · 1 missed | ||||||
| Phase 4 | NCT07655440 | Jul 2026 → Jul 2031 expected | migraine disorder, tinnitus, vestibular disorder | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05284019 | Mar 2022 → Feb 2023 | migraine disorder | H. Lundbeck A/S | Terminated | No outcome recorded |
| Phase 4 | NCT04825678 | Jun 2021 → Sep 2023 | migraine disorder | Amgen | Completed | Mixed |
| Phase 4 | NCT04265755 | Oct 2020 → Jan 2023 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT04674020 | Oct 2020 → Jul 2025 | migraine disorder | Danish Headache Center | Unknown | No outcome recorded |
| Phase 4 | NCT04465357 | Oct 2020 → Jun 2022 | migraine disorder | Merle Diamond | Completed | No outcome recorded |
| Phase 4 | NCT04592952 | Oct 2020 → Aug 2025 | migraine disorder | Danish Headache Center | Unknown | Missed primary |
| Phase 4 | NCT04603976 | Sep 2020 → Oct 2022 | migraine disorder | Danish Headache Center | Unknown | No outcome recorded |
| Phase 4 | NCT04252742 | Sep 2020 → Oct 2023 | migraine disorder | Amgen | Completed | Met primary |
| Phase 4 | NCT03912337 | Dec 2019 → Jul 2021 | migraine disorder | Amgen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04084314 | Sep 2019 → Feb 2023 | migraine disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT03977649 | Jul 2019 → Jul 2021 | migraine disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT03927144 | May 2019 → Oct 2021 | migraine disorder | Amgen | Completed | Met primary |
| Phase 4 | NCT03773562 | Mar 2019 → Jun 2022 | migraine disorder | Mayo Clinic | Completed | Met primary |
| Phase 4 | NCT03828539 | Feb 2019 → Jul 2020 | migraine disorder | Novartis Pharmaceuticals | Completed | Met primary |
| Phase not applicable2 trials | ||||||
| — | NCT04659226 | Jul 2021 → Dec 2022 | migraine disorder | University of L'Aquila | Completed | No outcome recorded |
| — | NCT04452929 | Jul 2020 → Feb 2022 | migraine with aura, migraine without aura | Danish Headache Center | Unknown | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 2 | NCT05142228 Comparator | May → Oct 2022 | cranial nerve neuropathy | University of Maryland, Baltimore | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05162027 Comparator | May 2022 → Jan 2023 | temporomandibular joint disorder | University of Maryland, Baltimore | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04884763 Comparator | Nov 2021 → Jan 2024 | temporomandibular joint disorder | Indiana University | Completed | No outcome recorded |
| Phase 2 | NCT04054024 Comparator | Oct 2019 → Oct 2021 | trigeminal neuralgia | Danish Headache Center | Unknown | No outcome recorded |
| Phase 4 | NCT04249427 Comparator | Feb 2021 → Jul 2023 | persistent idiopathic facial pain, sinusitis | David Jang, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT04294147 Comparator | Oct 2020 → Mar 2021 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT03971071 Comparator | Oct 2019 → Dec 2022 | migraine disorder | Amgen | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 43
| Date | Issuer | Release |
|---|---|---|
| 2022-09-01 | Amgen | Regulatory アムジェンの片頭痛発作の発症抑制薬
「アイモビーグ® 皮下注70mgペン」の在宅自己注射が保険適用に amgen.co.jp ↗
アムジェン株式会社（本社：東京、代表取締役社長：スティーブ・スギノ、以下「当社」）は本日、ヒト抗CGRP受容体モノクローナル抗体製剤「アイモビーグ®皮下注70mgペン」（一般名：エレヌマブ（遺伝子組換え）、以下「アイモビーグ」）が、厚生労働省の告示により、在宅自己注射指導管理料が算定可能な薬剤となり、9月1日から在宅自己注射の保険適用が認められることをお知らせします。 |
| 2021-11-08 | Novartis Pharmaceuticals | Results Novartis announces new publication in Cephalalgia of data showcasing superior tolerability and efficacy of Aimovig® (erenumab) compared with topiramate in migraine prevention novartis.com ↗ |
| 2021-11-08 | Amgen | Results First And Only Randomized, Double-blind, Head-to-head Study Comparing Aimovig® (erenumab-aooe), An Anti-CGRP Pathway Therapy, To Topiramate Published In Cephalalgia amgen.com ↗
In this head-to-head Phase IV study, patients in the Aimovig arm demonstrated a significantly lower discontinuation rate due to adverse events versus patients in the topiramate arm (10.6% versus 38.9%). |
| 2021-06-23 | Amgen | Regulatory Amgen Announces Approval Of Aimovig® (Erenumab) In Japan For The Suppression Of Onset Of Migraine Attacks In Adults amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the Japanese Ministry of Health, Labour and Welfare has granted marketing approval for Aimovig ® (erenumab) for the suppression of onset of migraine attacks in adults. |
| 2021-06-03 | Eli Lilly and Company | Results Lilly Reveals Critical Barriers to Optimal Migraine Care and Insights From Novel Clinical and Patient-Centric Real-World Evidence, Supporting Lilly's Preventive and Acute Treatment Portfolio at AHS 2021 lilly.com ↗
greater probability of patient preference for the Emgality auto-injector profile compared to Aimovig® (erenumab) and AJOVY® (fremanezumab) device characteristics in a survey. |
| 2020-11-02 | Novartis Pharmaceuticals | Results Novartis announces positive results from a Phase IV study showing superior tolerability and efficacy of Aimovig® (erenumab) compared with topiramate in migraine prevention novartis.com ↗
The results of HER-MES showed that Aimovig had a superior tolerability and efficacy profile than topiramate, with less discontinuation over the course of the 24-week treatment phase. |
| 2020-10-03 | Amgen | Results Amgen Announces Five-Year Data That Reinforce The Safety And Efficacy Profile Of Aimovig® (erenumab-aooe) In Adult Patients With Episodic Migraine amgen.com ↗
Results from the five-year, open-label treatment period of a Phase 2 study in episodic migraine prevention (NCT01952574) showed Aimovig helped patients achieve sustained reductions in monthly migraine days (MMD) and in use of acute migraine-specific medication (AMSM), such as triptans. |
| 2020-04-16 | Novartis Pharmaceuticals | Results Novartis announces data in Neurology reinforcing the real-world and long-term effectiveness and safety of Aimovig® as a preventive treatment across the full spectrum of migraine novartis.com ↗
The data strengthens the role Aimovig as a preventive migraine treatment and confirms its real-world and long-term safety and efficacy benefit in patients with episodic and chronic migraine. |
| 2019-09-09 | Novartis Pharmaceuticals | Results Novartis data confirm long-term efficacy and safety of Aimovig® for majority of patients with episodic migraine novartis.com ↗
4.5-year data show 77% of the patients who continued on treatment experienced at least a 50% reduction in monthly migraine days (MMD) at the last month of assessment |
| 2019-07-01 | Novartis Pharmaceuticals | Results Novartis data underpin long-term efficacy of Aimovig® where other treatments have failed novartis.com ↗
This open-label extension phase (OLEP) confirms Aimovig ® (erenumab) 140 mg decreases the number of MMD as well as migraine-specific medication days (MSMD). |
| 2019-07-01 | Novartis Pharmaceuticals | Results Novartis data show Aimovig® cuts acute migraine medication days by half in patients who failed prior preventive therapies novartis.com ↗
STRIVE data show that 55% of patients on Aimovig 140 mg experienced at least a 50% reduction in the number of monthly migraine days requiring acute medication at week 52 |
| 2019-05-02 | Novartis Pharmaceuticals | Results Novartis to highlight extensive long-term safety and efficacy data of Aimovig® across the spectrum of migraine at AAN novartis.com ↗
After long-term Aimovig (erenumab) treatment, two-thirds of chronic migraine patients converted to episodic migraine, experiencing 11 fewer migraine days per month on average |
| 2019-05-02 | Amgen | Results Amgen To Highlight Extensive Long-Term Safety And Efficacy Data Of Aimovig® (erenumab-aooe) Across The Spectrum Of Migraine At AAN Annual Meeting amgen.com ↗
Additionally, one-year results of the Phase 3 STRIVE study reinforced the sustained efficacy and safety profile of Aimovig in patients with episodic migraine, including patients who had tried and failed prior preventive treatments. |
| 2019-04-30 | Novartis Pharmaceuticals | Results New data at AAN reinforce Novartis commitment to transforming the lives of people of all ages who live with neurological conditions novartis.com ↗
With the greatest real world exposure and longest clinical trial experience of any anti-CGRP therapy, Aimovig ® (erenumab) continues to show positive long-term safety and efficacy across the spectrum of migraine with new clinical trial data[14]-[22] |
| 2018-10-23 | Novartis Pharmaceuticals | Results Novartis announces Lancet publication of pioneering study in migraine prevention showing efficacy of Aimovig® where other treatments have failed novartis.com ↗
Patients treated with Aimovig had significant improvements on all primary and secondary endpoints of the study. |
| 2018-07-30 | Novartis Pharmaceuticals | Regulatory Novartis marks a new era for migraine patients with the EU approval of Aimovig®, a first-of-its-kind treatment specifically designed for migraine prevention novartis.com ↗
Novartis announced today that the European Commission (EC) approved Aimovig ® (erenumab) for the prevention of migraine in adults experiencing four or more migraine days per month. |
| 2018-06-28 | Novartis Pharmaceuticals | Results Novartis presents new data demonstrating long-term efficacy, safety and tolerability of Aimovig® (erenumab) in patients with chronic and episodic migraine novartis.com ↗
Novartis today announced the results of two open-label extension studies (OLE) of Aimovig ® (erenumab) in patients with chronic and episodic migraine, which will be presented at the 60 th Annual Scientific Meeting of the American Headache Society in San Francisco[1],[2]. |
| 2018-06-28 | Amgen | Results Amgen And Novartis Present New Data Demonstrating Long-Term Efficacy, Safety And Tolerability Of Aimovig™ (erenumab-aooe) In Patients With Chronic And Episodic Migraine amgen.com ↗
Results from a one-year study in chronic migraine patients reinforced the established safety and efficacy profile of Aimovig in long-term use. |
| 2018-06-01 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for Aimovig® (erenumab) for the prevention of migraine novartis.com ↗
Basel, June 1, 2018 - Novartis today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for Aimovig ® (erenumab) for the prevention of migraine in adults who have at least four migraine days per month. |
| 2018-05-18 | Novartis Pharmaceuticals | Regulatory Novartis and Amgen announce FDA approval of Aimovig(TM) (erenumab), a novel treatment developed specifically for migraine prevention novartis.com ↗
Novartis today announced that the US Food and Drug Administration (FDA) has approved Aimovig TM (erenumab) for the preventive treatment of migraine in adults. |
| 2018-05-17 | Amgen | Regulatory FDA Approves Aimovig™ (erenumab-aooe), A Novel Treatment Developed Specifically For Migraine Prevention amgen.com ↗
Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Aimovig™ (erenumab-aooe) for the preventive treatment of migraine in adults. |
| 2018-04-17 | Novartis Pharmaceuticals | Results Novartis presents first-of-its-kind evidence at AAN reinforcing robust and consistent efficacy of AimovigTM* (erenumab) for migraine patients with multiple treatment failures novartis.com ↗
Novartis today announced full results from the Phase IIIb LIBERTY trial of Aimovig (erenumab, AMG 334) in episodic migraine patients who had previously failed two to four preventive treatments, due to lack of efficacy or intolerable side effects[1]. |
| 2018-04-17 | Amgen | Results Amgen Presents First-Of-Its-Kind Data At AAN Annual Meeting Reinforcing Robust And Consistent Efficacy Of Aimovig™ (erenumab) For Migraine Patients With Multiple Treatment Failures amgen.com ↗
Amgen (NASDAQ: AMGN) today announced full results from the Phase 3b LIBERTY trial of Aimovig™ (erenumab) in episodic migraine patients who had previously failed two to four preventive treatments, due to lack of efficacy or to intolerable side effects. |
| 2018-01-22 | Novartis Pharmaceuticals | Results Novartis reports erenumab met all primary and secondary endpoints in unique Phase IIIb study in episodic migraine patients who have failed multiple prior preventive treatments novartis.com ↗
The study met its primary endpoint, with significantly more patients taking erenumab experiencing at least a 50% reduction from baseline in their monthly migraine days as compared to placebo. |
| 2018-01-22 | Amgen | Results Amgen Reports Aimovig™ (Erenumab) Met All Primary And Secondary Endpoints In Unique Phase 3b Study In Episodic Migraine Patients Who Have Failed Multiple Prior Preventive Treatments amgen.com ↗
The study met its primary endpoint, with significantly more patients taking Aimovig experiencing at least a 50 percent reduction from baseline in their monthly migraine days as compared to placebo. |
| 2017-11-29 | Novartis Pharmaceuticals | Results Novartis announces Phase III STRIVE data published in NEJM demonstrating significant and sustained efficacy of erenumab (AMG334) in migraine prevention novartis.com ↗
Novartis today announced that the New England Journal of Medicine (NEJM) published positive results from the six-month Phase III STRIVE study evaluating erenumab in the prevention of episodic migraine (defined in STRIVE as 4 to 14 migraine days per month)[1]. |
| 2017-11-29 | Amgen | Results Aimovig™ (erenumab) Phase 3 STRIVE Data Published In The New England Journal Of Medicine Demonstrate Significant, Sustained Efficacy In Migraine Prevention amgen.com ↗
Amgen (NASDAQ: AMGN) today announced that the New England Journal of Medicine (NEJM) published positive results from the six-month Phase 3 STRIVE study evaluating Aimovig™ (erenumab) versus placebo for the prevention of episodic migraine (between four and 14 migraine days per month). |
| 2017-09-07 | Novartis Pharmaceuticals | Results Novartis presents new analysis demonstrating AMG 334 (erenumab) significantly reduced monthly migraine days in patients who failed previous preventive therapies novartis.com ↗
A new analysis from a pivotal Phase II study shows erenumab reduced monthly migraine days in patients with chronic migraine for whom previous preventive treatments have failed[1]. |
| 2017-09-07 | Amgen | Results New Data Demonstrate Aimovig™ (erenumab) Reduced Monthly Migraine Days In Patients Who Failed Previous Preventive Therapies amgen.com ↗
The data include a pre-planned sub-analysis from the pivotal Phase 2 chronic migraine study, demonstrating that Aimovig reduced the number of monthly migraine days (MMDs) in patients who have failed previous preventive therapies. |
| 2017-07-20 | Amgen | Regulatory FDA Accepts Biologics License Application For Aimovig™ (erenumab) amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has accepted for review the Biologics License Application (BLA) for Aimovig™ (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month. |
| 2017-06-21 | Novartis Pharmaceuticals | Regulatory Novartis achieves important regulatory milestone for AMG 334 (erenumab) in migraine prevention with EMA filing acceptance novartis.com ↗
Basel, June 21, 2017 - Novartis today announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for AMG 334 (erenumab) for the prevention of migraine. |
| 2017-06-08 | Novartis Pharmaceuticals | Results Novartis presents data demonstrating efficacy of AMG 334 (erenumab) in migraine prevention at the American Headache Society Annual Meeting novartis.com ↗
Data from the comprehensive clinical program show AMG 334 (erenumab) is safe and effective at preventing migraine in patients with 4 or more migraine days per month |
| 2017-05-18 | Amgen | Regulatory Amgen Submits Biologics License Application To The FDA For Erenumab amgen.com ↗
Amgen (NASDAQ:AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration ( FDA ) for erenumab to prevent migraine. |
| 2016-11-16 | Novartis Pharmaceuticals | Results Novartis announces AMG 334 significantly reduces monthly migraine days in second pivotal Phase III episodic migraine study novartis.com ↗
Novartis today announced positive topline results from the global Phase III STRIVE study, evaluating the efficacy and safety of the fully human monoclonal antibody AMG 334 (erenumab) in episodic migraine prevention. |
| 2016-11-16 | Amgen | Results Amgen Announces Erenumab Significantly Reduces Monthly Migraine Days In Patients With Episodic Migraine In Second Phase 3 Study amgen.com ↗
These data showed the STRIVE study met the primary endpoint, demonstrating statistically significant reductions from baseline in monthly migraine days in patients with episodic migraine treated with either 70 mg or 140 mg erenumab compared with placebo. |
| 2016-09-28 | Novartis Pharmaceuticals | Results Novartis announces Phase III study shows AMG 334 significantly reduces monthly migraine days in people with episodic migraine novartis.com ↗
Novartis today announced positive topline results from ARISE, the first Phase III study evaluating the efficacy and safety of monthly subcutaneous AMG 334 (erenumab) 70mg in episodic migraine prevention. |
| 2016-09-28 | Amgen | Results Amgen Announces Erenumab Significantly Reduces Monthly Migraine Days In Patients With Episodic Migraine In First Phase 3 Study amgen.com ↗
These data showed the ARISE study met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients with episodic migraine treated with erenumab compared with placebo at 12 weeks. |
| 2016-09-15 | Novartis Pharmaceuticals | Results Novartis presents new positive data at EHMTIC showing AMG 334 significantly reduces monthly migraine days in chronic migraine novartis.com ↗
Novartis today announced detailed Phase II results showing the fully human monoclonal antibody AMG 334 (erenumab) demonstrated a statistically significant reduction in monthly migraine days compared with placebo in patients with chronic migraine (CM). |
| 2016-09-15 | Amgen | Results Amgen Presents Positive Data At EHMTIC 2016 Demonstrating Erenumab Significantly Reduces Monthly Migraine Days In Patients With Chronic Migraine amgen.com ↗
Amgen (NASDAQ:AMGN) today announced detailed global Phase 2 results showing erenumab demonstrated a statistically significant reduction in monthly migraine days compared with placebo in patients with chronic migraine. |
| 2016-06-08 | Novartis Pharmaceuticals | Results Novartis announces AMG 334 significantly reduces patients' monthly migraine days in phase II study of chronic migraine prevention novartis.com ↗
Novartis today announced positive first results from the global phase II 20120295 study, investigating the efficacy and safety of the fully human monoclonal antibody AMG 334 (erenumab) in chronic migraine prevention. |
| 2016-06-08 | Amgen | Results Amgen Announces Erenumab (AMG 334) Significantly Reduces Patients' Monthly Migraine Days In Phase 2 Study For The Prevention Of Chronic Migraine amgen.com ↗
Amgen (NASDAQ:AMGN) today announced positive top-line results from the global Phase 2 study evaluating the efficacy and safety of erenumab (AMG 334) in chronic migraine prevention. |
| 2015-06-19 | Amgen | Results Amgen Presents Open-Label Extension Data From Ongoing Phase 2 Study Of AMG 334 In The Prevention Of Episodic Migraine amgen.com ↗
Amgen (NASDAQ: AMGN) today announced positive interim results from its open-label extension of the global Phase 2, double-blind, placebo-controlled study evaluating the safety and efficacy of AMG 334 for the prevention of episodic migraine. |
| 2015-05-15 | Amgen | Results Amgen Presents First Phase 2 Data For AMG 334 In The Prevention Of Episodic Migraine amgen.com ↗
Amgen (NASDAQ:AMGN) today announced the first results from its global Phase 2, double-blind, placebo-controlled study evaluating the efficacy and safety of AMG 334 for the prevention of episodic migraine. |
All press releases naming this drug 47 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Erenumab | “Erenumab, a monoclonal antibody acting on the calcitonin gene-related peptide (CGRP) receptor, is an effective and safe migraine-specific preventive drug.” NCT04659226 ↗45“Erenumab is a novel CGRP-receptor antibody with preventive efficacy in migraine.” PMID 30360965 ↗ Oct 2018 |
| Known as | Aimovig | “Erenumab-Aooe 140 MG/ML [Aimovig]” NCT04465357 ↗ |
| Known as | AMG 334 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03974360 ↗ |
| Known as | AMG 334, Aimovig | “AMG 334, Aimovig™” NCT02630459 ↗ |
| Known as | Erenumab-aooe | “Erenumab-aooe is a fully human monoclonal antibody that targets the CGRP receptor, and interrupts its downstream effects.” NCT03912337 ↗ |
| Action | Inhibit | “Selective blockade of the canonical calcitonin gene-related peptide receptor with erenumab for migraine prevention” PMID 31852816 ↗ Dec 20191“Calcitonin gene-related peptide type 1 receptor antagonist” CHEMBL3833329 ↗ |
| Modality | Monoclonal antibody | “a fully human monoclonal antibody” PMID 35978286 ↗ Aug 2022 |
| Route | Subcutaneous | “Administered by subcutaneous injection” NCT01688739 ↗ |
| Target | CALCRL | “Calcitonin gene-related peptide type 1 receptor antagonist” CHEMBL3833329 ↗ |