Drugs / BIIB019
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | ZINBRYTA | multiple sclerosis | 2015-03-27 | “Biogen and AbbVie announced that the European Medicines Agency (EMA) has validated the companies' Marketing Authorisation Application (MAA) for ZINBRYTA” abbvie.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01929746 | Oct 2013 → Mar 2014 | — | Biogen | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00870740 | Feb 2009 → May 2012 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT01797965 | Feb 2013 → Sep 2018 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT01462318 | Nov 2011 → Jan 2016 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT01064401 | May 2010 → Mar 2014 | relapsing-remitting multiple sclerosis | Biogen | Completed | Met primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2016-07-05 | Biogen | Regulatory Biogen and AbbVie’s Once-Monthly ZINBRYTA™ (Daclizumab) Approved in European Union for Treatment of Multiple Sclerosis biogen.com ↗
The European Commission (EC) has granted marketing authorization for ZINBRYTA™ (daclizumab) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today. |
| 2016-05-27 | AbbVie | Regulatory Biogen and AbbVie Receive FDA Approval of Once-Monthly ZINBRYTA™ (daclizumab) for Multiple Sclerosis abbvie.com ↗
The U.S. Food and Drug Administration (FDA) approved ZINBRYTA™ (daclizumab), a new once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today. |
| 2016-04-29 | Biogen | Regulatory Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis biogen.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for ZINBRYTA™ (daclizumab) intended for the treatment of relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today. |
| 2015-10-08 | Biogen | Results Results from ZINBRYTA™ (Daclizumab High-Yield Process) Phase 3 DECIDE Study Highlighting Efficacy Compared to Interferon Beta-1a Published in the New England Journal of Medicine and Presented at ECTRIMS biogen.com ↗
Lead investigators on behalf of Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) presented these new findings today at the 31st Congress of the European Committee for Treatment and Research in MS (ECTRIMS) in Barcelona, Spain (7-10 October). |
| 2015-03-27 | Biogen | Regulatory European Medicines Agency Validates Marketing Authorisation Application for ZINBRYTA™ (Daclizumab High-Yield Process) for Treatment of MS biogen.com ↗
Today Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced that the European Medicines Agency (EMA) has validated the companies’ Marketing Authorisation Application (MAA) for ZINBRYTA™ (daclizumab high-yield process) for the treatment of relapsing forms of multiple sclerosis (MS) in the European Union (EU). |
| 2014-06-16 | Biogen | Results Biogen Idec and AbbVie Announce Positive Top-Line Results from Phase 3 Study Investigating Daclizumab High-Yield Process in Multiple Sclerosis biogen.com ↗
Results showed that DAC HYP was superior on the study’s primary endpoint, demonstrating a statistically significant 45 percent reduction in annualized relapse rate (ARR) compared to IFN β-1a (p<0.0001). |
| 2013-04-04 | Biogen | Results The Lancet Publishes SELECT Study Evaluating Efficacy and Safety of Daclizumab HYP in Multiple Sclerosis biogen.com ↗
In addition, results demonstrated that DAC HYP reduced multiple sclerosis (MS) brain lesions compared to placebo. |
| 2011-08-09 | Biogen | Results Biogen Idec and Abbott Announce Positive Top-Line Results from the First Registrational Trial for Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis biogen.com ↗
Findings showed that DAC HYP reduced the risk of sustained disability progression at one year by 57 percent in the 150 mg dose arm and by 43 percent in the 300 mg dose arm compared to placebo. |
All press releases naming this drug 17 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BIIB019 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01462318 ↗ |
| Known as | Daclizumab | “BIIB019 (Daclizumab)” NCT01462318 ↗1“BIIB019 (Daclizumab)” NCT01797965 ↗ |
| Route | Subcutaneous | “150 mg subcutaneous (SC) injection” NCT00870740 ↗ |