Drugs / LY2963016
LY2963016
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | diabetes mellitus, noninsulin-dependent, 2 | 2013-12-20 | “Lilly, and its alliance partner Boehringer Ingelheim, recently announced the FDA had accepted the filing of the New Drug Application (NDA) for LY2963016” lilly.com ↗ “the U.S. Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) for LY2963016” lilly.com ↗ “the U.S. Food and Drug Administration accepted the filing of the New Drug Application for LY2963016” lilly.com ↗ |
| Filed | EU (EMA) | — | diabetes mellitus, noninsulin-dependent, 2 | 2013-07-08 | “accepted for review by the European Medicines Agency (EMA).” lilly.com ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT02955953 | Nov 2016 → Jan 2017 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01688635 | Sep 2012 → Feb 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01634165 | Jul → Sep 2012 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01600950 | May → Jul 2012 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01476345 | Nov 2011 → Jul 2012 | diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01374178 | Jun → Jul 2011 | diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 35 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT03338023 | Mar 2018 → Mar 2020 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT03338010 | Mar 2018 → Mar 2020 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02302716 | Dec 2014 → Jul 2016 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01421459 | Sep 2011 → Sep 2012 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01421147 | Aug 2011 → Aug 2012 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2014-09-10 | Eli Lilly and Company | Regulatory European Commission grants Lilly and Boehringer Ingelheim's insulin glargine product marketing authorisation in Europe lilly.com ↗
The European Commission (EC) granted marketing authorisation for Eli Lilly and Company and Boehringer Ingelheim's insulin glargine product, indicated to treat diabetes in adults, adolescents and children aged 2 years and above. |
| 2014-08-18 | Eli Lilly and Company | Regulatory FDA Grants Tentative Approval for Lilly and Boehringer Ingelheim's Basaglar™ (insulin glargine injection) lilly.com ↗
The U.S. Food and Drug Administration (FDA) today granted tentative approval for Basaglar™ (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. |
| 2014-06-27 | Eli Lilly and Company | Regulatory CHMP Recommends Lilly and Boehringer Ingelheim's Investigational New Insulin Glargine Product for Approval in the European Union lilly.com ↗
The Committee for Medicinal Products for Human Use (CHMP) today issued a positive opinion recommending approval for the investigational compound LY2963016, a new insulin glargine product, for the treatment of type 1 and type 2 diabetes. |
| 2014-06-14 | Eli Lilly and Company | Results Studies Show Investigational New Insulin Glargine Product from Lilly and Boehringer Ingelheim Similar Safety and Efficacy Profile to Lantus® lilly.com ↗
For the first time today, Eli Lilly and Company (NYSE:LLY) and Boehringer Ingelheim Pharmaceuticals Inc. presented data showing that LY2963016, the alliance's investigational new insulin glargine product, has a similar safety and efficacy profile to currently marketed insulin glargine (Lantus®). |
| 2014-06-09 | Eli Lilly and Company | Results Diabetes: Boehringer Ingelheim and Eli Lilly and Company Alliance to Feature 43 Presentations at the 74th American Diabetes Association Scientific Sessions® lilly.com ↗
Similar Efficacy and Safety with LY2963016 Insulin Glargine Compared with Lantus® Insulin Glargine in Patients with T2D: the ELEMENT 2 Study |
| 2013-12-20 | Eli Lilly and Company | Regulatory Eli Lilly and Company and Boehringer Ingelheim announce new drug application filing in the U.S. for new insulin glargine product lilly.com ↗
Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) for LY2963016, an investigational basal (long-acting) insulin. |
| 2013-07-08 | Eli Lilly and Company | Regulatory Eli Lilly and Company and Boehringer Ingelheim announce regulatory submission for new insulin glargine biosimilar product lilly.com ↗
Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim today announced that the companies' marketing authorisation application (MAA) for LY2963016, an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes, has been accepted for review by the European Medicines Agency (EMA). |
All press releases naming this drug 23 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LY2963016 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01688635 ↗ |
| Known as | Basaglar | “Lilly insulin glargine (LY IGlar; Basaglar®) and the reference insulin glargine product (IGlar; Lantus®) are basal insulin glargine analogs with identical amino acid sequence...” PMID 31119716 ↗ Aug 2019 |
| Known as | insulin glargine | “INTRODUCTION: LY2963016 insulin glargine (LY IGlar), a biosimilar of Lantus® insulin glargine (IGlar), demonstrated comparable efficacy and safety versus the reference product...” PMID 35471721 ↗ Apr 20221“INTRODUCTION: LY2963016 insulin glargine (LY IGlar) and Lantus® (IGlar), both with identical primary amino acid sequences, were compared in two phase 3 studies for intrapatient...” PMID 29855972 ↗ May 2018 |
| Known as | Lilly insulin glargine | “Lilly insulin glargine (LY IGlar; Basaglar®) and the reference insulin glargine product (IGlar; Lantus®) are basal insulin glargine analogs with identical amino acid sequence...” PMID 31119716 ↗ Aug 2019 |
| Known as | LY IGlar | “INTRODUCTION: LY2963016 insulin glargine (LY IGlar), a biosimilar of Lantus® insulin glargine (IGlar), demonstrated comparable efficacy and safety versus the reference product...” PMID 35471721 ↗ Apr 20222“Lilly insulin glargine (LY IGlar; Basaglar®) and the reference insulin glargine product (IGlar; Lantus®) are basal insulin glargine analogs with identical amino acid sequence...” PMID 31119716 ↗ Aug 2019 “INTRODUCTION: LY2963016 insulin glargine (LY IGlar) and Lantus® (IGlar), both with identical primary amino acid sequences, were compared in two phase 3 studies for intrapatient...” PMID 29855972 ↗ May 2018 |
| Modality | Protein / enzyme biologic | “both with identical primary amino acid sequences” PMID 29855972 ↗ May 2018 |
| Route | Subcutaneous | “Administered subcutaneously” NCT01374178 ↗ |