Drugs / peginterferon beta-1a
peginterferon beta-1a
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed multiple sclerosis 2 milestones | |||||
| Filed | EU (EMA) | PLEGRIDY | multiple sclerosis | — | “The Marketing Authorisation Application (MAA) of PLEGRIDY for review in the European Union was also validated by the European Medicines Agency.” biogen.com ↗ “Biogen recently submitted regulatory filings in the U.S. and the European Union for intramuscular (IM) injection of PLEGRIDY” biogen.com ↗ “In June 2013, Biogen Idec also submitted a Marketing Authorisation Application for PLEGRIDY to the EMA.” biogen.com ↗ |
| Filed | US (FDA) | PLEGRIDY | multiple sclerosis | — | “The U.S. Food and Drug Administration (FDA) has accepted Biogen Idec’s Biologics License Application (BLA) for marketing approval of PLEGRIDY in the United States” biogen.com ↗ “Biogen recently submitted regulatory filings in the U.S. and the European Union for intramuscular (IM) injection of PLEGRIDY” biogen.com ↗ “In May 2013, Biogen Idec announced it submitted a BLA to the FDA for approval of PLEGRIDY™ (peginterferon beta-1a)” biogen.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | PLEGRIDY | — | 2020-03-27 – 2021-01-29 | fda.gov ↗ |
| Approved | US (FDA) | PLEGRIDY | — | 2014-08-15 | fda.gov ↗ |
| Approved | EU (EMA) | Plegridy | — | 2014-07-18 | europa.eu ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT04183491 | Feb 2020 → Jan 2021 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT02269930 | Oct → Dec 2014 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01978652 | Dec 2013 → Feb 2014 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01119781 | May 2010 → Aug 2011 | impaired renal function disease | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT02125578 | Mar → May 2008 | — | Biogen | Completed | No outcome recorded |
| Phase 37 trials · 3 met primary | ||||||
| Phase 3 | NCT03958877 | Oct 2019 → May 2027 expected | relapsing-remitting multiple sclerosis | Biogen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03870763 | Mar 2019 → Jul 2022 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT05242133 | Dec 2017 → Apr 2022 | relapsing-remitting multiple sclerosis | Cinnagen | Completed | Met primary |
| Phase 3 | NCT01939002 | Nov 2013 → Oct 2015 | multiple sclerosis | Biogen | Completed | Met primary |
| Phase 3 | NCT01332019 | Apr 2011 → Oct 2015 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT01337427 | Aug 2010 → Aug 2013 | relapsing-remitting multiple sclerosis | Johns Hopkins University | Withdrawn | No outcome recorded |
| Phase 3 | NCT00906399 | Jun 2009 → Oct 2012 | relapsing-remitting multiple sclerosis | Biogen | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT03535298 | Jan 2019 → Jul 2027 expected | relapsing-remitting multiple sclerosis | The Cleveland Clinic | Active not recruiting | No outcome recorded |
| Phase 4 | NCT02587065 | Feb 2016 → Oct 2017 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT02234869 | Oct 2014 → Feb 2017 | multiple sclerosis | Biogen | Withdrawn | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 3 | NCT04788615 Comparator | Jul 2021 → Nov 2025 | multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04552379 Comparator | Dec 2020 → May 2021 | COVID-19 | Pontificia Universidad Catolica de Chile | Completed | No outcome recorded |
| Phase 4 | NCT03424733 Background | Sep 2017 → May 2020 | multiple sclerosis | Holy Name Medical Center, Inc. | Unknown | Missed primary |
| Phase 4 | NCT03177083 Comparator | Jan 2017 → Oct 2020 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT02568111 Background | Feb → Aug 2016 | relapsing-remitting multiple sclerosis | Biogen | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2022-10-26 | Biogen | Results New Data at ECTRIMS 2022 Highlight Biogen’s Commitment to Advancing Individualized Disease Management for People Living with MS biogen.com ↗
Data on interferon exposure during pregnancy showed that treatment with PLEGRIDY ® (peginterferon beta-1a) or AVONEX ® (interferon beta-1a) did not negatively impact child development |
| 2021-10-13 | Biogen | Results New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis biogen.com ↗
MS PATHS data indicate that 100 percent of people with MS treated with natalizumab, interferons or fumarates achieved an antibody response following COVID-19 vaccination |
| 2021-02-01 | Biogen | Regulatory Biogen Announces FDA Approval of PLEGRIDY® (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis biogen.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved a new intramuscular (IM) injection route of administration for PLEGRIDY ® (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (MS). |
| 2020-12-21 | Biogen | Regulatory The European Commission Grants Marketing Authorization for PLEGRIDY® (peginterferon beta-1a) Intramuscular Administration for Relapsing-Remitting Multiple Sclerosis biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission (EC) has approved a new intramuscular (IM) injection route of administration for PLEGRIDY ® (peginterferon beta-1a) for the treatment of relapsing-remitting multiple sclerosis (MS). |
| 2020-09-11 | Biogen | Results New Data at ACTRIMS-ECTRIMS Meeting Showcase Safety and Efficacy of Biogen’s Industry-Leading MS Portfolio biogen.com ↗
Clinical outcomes in people with MS aged 60 or older (n=286), compared to those under 60 (n=729), indicate that PLEGRIDY and AVONEX may provide real-world treatment benefits over two years in both age groups. |
| 2020-05-19 | Biogen | Regulatory New Data at AAN Showcase Biogen’s Commitment to Advancing Innovation in MS biogen.com ↗
In addition to the presented data, Biogen recently submitted regulatory filings in the U.S. and the European Union for intramuscular (IM) injection of PLEGRIDY ® (peginterferon beta-1a). |
| 2019-09-23 | Biogen | Regulatory Interferon Beta Treatments, Including PLEGRIDY® (peginterferon beta-1a) and AVONEX® (interferon beta-1a), Receive Positive CHMP Opinion for Use During Pregnancy and Breastfeeding biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP), part of the of the European Medicines Agency (EMA), recommended an update to marketing authorizations of approved interferon beta treatments, including PLEGRIDY ® (peginterferon beta-1a) and AVONEX ® (interferon beta-1a), to remove pregnancy contraindications and, where clinically needed, to allow use during pregnancy and breastfeeding in women with relapsing multiple sclerosis (MS). |
| 2019-09-12 | Biogen | Results New Research Demonstrate Biogen’s Continued Commitment to Improve Care of Patients with Multiple Sclerosis Across Treatment Spectrum biogen.com ↗
Additional findings confirm exposure to interferon beta, including PLEGRIDY ® (peginterferon beta-1a) and AVONEX ® (interferon beta-1a) , is not expected to impact pregnancy or infant outcomes |
| 2018-10-02 | Biogen | Results Biogen Highlights at ECTRIMS 2018 Data on Its Industry-Leading Multiple Sclerosis Portfolio and a Range of Initiatives Aimed at Transforming Patient Care biogen.com ↗
A newly diagnosed subgroup analysis of ADVANCE demonstrates PLEGRIDY lowered the risk of chronic black holes evolving from acute MRI lesions. |
| 2016-09-08 | Biogen | Results Biogen Demonstrates Commitment to Improving Patient Outcomes with Study on Burden of MS and New Clinical Data from Its Leading MS Portfolio biogen.com ↗
PLEGRIDY SC Peginterferon Beta-1a Every Two Weeks Demonstrated Better Clinical Outcomes than SC Interferon Beta-1a TIW in Patients with RMS, Using a Matching-Adjusted Comparison of Seven Phase 3 Trials |
| 2016-04-12 | Biogen | Results Biogen Data at 2016 AAN Annual Meeting Highlight Its Expansive Portfolio of MS Therapies That Meets Diverse Needs of Patients biogen.com ↗
Peginterferon Beta-1a Reduces Conversion of MRI Lesions to Black Holes in Patients with Relapsing-Remitting Multiple Sclerosis |
| 2015-10-01 | Biogen | Results Biogen to Highlight Broad Research Commitment to MS Care at ECTRIMS Congress, Including New TECFIDERA® Data Demonstrating Importance of Early Treatment biogen.com ↗
Peginterferon Beta-1a Dosed Every Two Weeks Maintained Efficacy Over Three Years in Patients with Relapsing-Remitting Multiple Sclerosis |
| 2015-04-21 | Biogen | Results PLEGRIDY® (Peginterferon Beta-1a) Three-Year Data Presented at AAN Annual Meeting Support Long-Term Safety and Efficacy in Multiple Sclerosis Patients biogen.com ↗
Today Biogen (NASDAQ: BIIB) announced new data from the ATTAIN study which demonstrate the long-term safety and efficacy of PLEGRIDY ® (peginterferon beta-1a) over three years in people with relapsing-remitting multiple sclerosis (RRMS). |
| 2014-09-11 | Biogen | Results PLEGRIDY™ (Peginterferon Beta-1a) Two-Year Data Confirm Maintenance of Efficacy and Safety in Multiple Sclerosis Patients biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) announced new data from the second year of its Phase 3 ADVANCE clinical trial that show the positive treatment effects of PLEGRIDY™ (peginterferon beta-1a) were maintained in people with relapsing forms of multiple sclerosis (RMS) beyond the first year of the study. |
| 2014-08-15 | Biogen | Regulatory Biogen Idec’s PLEGRIDY™(Peginterferon Beta-1a) Approved in the US for the Treatment of Multiple Sclerosis biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved PLEGRIDY TM (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS). |
| 2014-07-23 | Biogen | Regulatory PLEGRIDY™ (Peginterferon beta-1a) Approved in the European Union for the Treatment of Multiple Sclerosis biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) announced that the European Commission (EC) has granted marketing authorization for PLEGRIDY TM (peginterferon beta-1a) as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). |
| 2014-05-23 | Biogen | Regulatory CHMP Adopts Positive Opinion for PLEGRIDY™ (Peginterferon Beta-1a) as a Treatment for Multiple Sclerosis in the European Union biogen.com ↗
“The CHMP’s positive opinion for PLEGRIDY marks an important milestone in bringing a meaningful treatment advance to people with MS in the EU,” said Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of Research and Development. |
| 2014-04-29 | Biogen | Results Biogen Idec to Present New Two-Year Data from the PLEGRIDY™ (Peginterferon Beta-1a) Phase 3 ADVANCE Study at AAN Annual Meeting biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) announced two-year data from its Phase 3 ADVANCE clinical trial for PLEGRIDY™ (peginterferon beta-1a) in people with relapsing forms of multiple sclerosis (RMS). |
| 2014-03-18 | Biogen | Regulatory Biogen Idec Receives Notification of PDUFA Date Extension for Plegridy™ (Peginterferon Beta-1a) biogen.com ↗
The FDA has indicated that the extension of the PDUFA date is required to allow additional time for review of the application. |
| 2013-10-01 | Biogen | Results New Data Analyses Show Significant Clinical and MRI Improvements with PLEGRIDY™ (Peginterferon Beta-1a) biogen.com ↗
Clinical and MRI data from the study demonstrated a reduction in relapses, disability progression and the number of MS lesions when compared to placebo, and further support the clinical efficacy profile of PLEGRIDY. |
| 2013-07-19 | Biogen | Regulatory US and EU Regulatory Authorities Accept PLEGRIDY™ (peginterferon beta-1a) Marketing Applications for Review biogen.com ↗
The U.S. Food and Drug Administration (FDA) has accepted Biogen Idec’s Biologics License Application (BLA) for marketing approval of PLEGRIDY in the United States and granted the company a standard review timeline. |
| 2013-05-21 | Biogen | Regulatory Biogen Idec Submits Application to FDA for Approval of PLEGRIDY™ (Peginterferon Beta-1a) in Multiple Sclerosis biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of PLEGRIDY™ (peginterferon beta-1a), the company’s pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (RMS). |
| 2013-03-20 | Biogen | Results Positive Year One Results from Biogen Idec Phase 3 ADVANCE Trial of PLEGRIDY™ (Peginterferon Beta-1a) Presented at AAN Meeting biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) announced the positive, full first-year results from its two-year pivotal Phase 3 ADVANCE study of PLEGRIDY™ (peginterferon beta-1a), the company’s investigational candidate for relapsing-remitting multiple sclerosis (RRMS) dosed once every two weeks or every four weeks. |
| 2013-01-24 | Biogen | Results Biogen Idec Announces Positive Top-Line Results from Phase 3 Study of Peginterferon Beta-1a in Multiple Sclerosis biogen.com ↗
The primary endpoint of ADVANCE, annualized relapse rate (ARR) at one year, was met for both the two-week and four-week dose regimens. |
| 2009-07-08 | Biogen | Regulatory Biogen Idec Receives Fast Track Designation from FDA for PEGylated Interferon Beta-1a for Relapsing Multiple Sclerosis biogen.com ↗
Biogen Idec (NASDAQ: BIIB) today announced the U.S. Food and Drug Administration (FDA) has granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis (RMS). |
All press releases naming this drug 26 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | peginterferon beta-1a | “Efficacy and safety of peginterferon beta-1a compared to interferon beta-1a in relapsing remitting multiple sclerosis patients” PMID 39217809 ↗ Aug 202414“Peg-Interferon beta-1a minimum dose of 63µg or maximum dose of 125µg every 2 weeks (14 days)” NCT04788615 ↗ “Drug: BIIB017 (peginterferon beta-1a)” NCT03958877 ↗ |
| Known as | BIIB017 | “BIIB017 (Peginterferon beta-1a)” NCT02234869 ↗ |
| Known as | PEG-IFN beta-1a | “This study clinically evaluated a novel PEGylated form of interferon beta-1a (PEG-IFN beta-1a), a potential first-line treatment for relapsing multiple sclerosis, in healthy volunteers.” PMID 21680782 ↗ Jun 2011 |
| Known as | Peginterferon beta | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108677 ↗ |
| Known as | peginterferon-β1a | “Peginterferon β-1a every 2 weeks increased achievement of no evidence of disease activity over 4 years in the ADVANCE and ATTAIN studies in patients with relapsing-remitting...” PMID 30181780 ↗ Aug 20181“Single-use autoinjector for peginterferon-β1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study.” PMID 25073663 ↗ Jul 2014 |
| Known as | PEGylated Interferon Beta-1a | “BIIB017 (PEGylated Interferon Beta-1a)” NCT02125578 ↗ |
| Known as | pegylated interferon-β1a | “a pegylated interferon-β1a in clinical development” PMID 25073663 ↗ Jul 2014 |
| Known as | Plegridy | “Plegridy (beta interferon)” NCT03535298 ↗ |
| Known as | Plegridy (beta interferon) | “Plegridy (beta interferon)” NCT03535298 ↗ |
| Modality | Protein / enzyme biologic | “PEGylated Interferon Beta-1a (BIIB017)” NCT01119781 ↗ |
| Route | Subcutaneous | “self-administered by subcutaneous injection” NCT00906399 ↗ |