logo
Plus   Neg
Share
Email

Allergan : FDA Accepts BLA And EMA Validates MAA For Abicipar Pegol

Allergan plc (AGN) and Molecular Partners said that the U.S. Food and Drug Administration has accepted a Biologics License Application or BLA and the European Medicines Agency or EMA has validated a Marketing Authorisation Application or MAA for Abicipar pegol, a novel, investigational DARPin therapy, in patients with neovascular (wet) age-related macular degeneration (nAMD).

The FDA is expected to take action on the BLA mid-2020. A decision from the European Commission is expected in the second half of 2020.

The BLA and MAA filings are based on data from two Phase 3 trials, CEDAR and SEQUOIA, which supported the non-inferior efficacy of the Abicipar quarterly dosing regimen to maintain vision gains with more than 50 percent fewer injections versus ranibizumab (13 vs. 6) dosed monthly in the first year.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Retail giant Walmart announced that back-to-school essentials are available at its stores with easy, contact-free shopping options. The announcement comes as the Trump administration initiated a campaign to press state authorities to reopen schools for Fall semester, even as COVID-19 pandemic is spreading out of control in the United States. Schools across the country remain shut since March. Bed Bath & Beyond, Inc. is planning to close around 200 mostly Bed Bath & Beyond stores over the next two years amid continuing struggles with Covid-19. The home improvement retailer, which reported a wider-than-expected loss in its first quarter with sharply lower sales, said the move is part of its plans to right-size its real estate portfolio and to cut costs. United Airlines has warned that 36,000 employees or about 45% of its U.S. workforce could be furloughed in October, due to continuing losses caused by the coronavirus pandemic and collapse in air travel, according to reports citing the company's memo sent to employees.
Follow RTT