Allergan's Filings For Abicipar Pegol Accepted In U.S/Europe
Zacks Investment Research | Sep 11, 2019 06:01AM ET
Allergan plc (NYSE:AGN) and partner Molecular Partners announced that the filings for their long-acting anti-VEGF product, abicipar pegol, developed for the treatment of age-related neovascular macular degeneration (nAMD), has been accepted for review by regulatory authorities in the United States and Europe.
While the FDA has accepted a biologics license application (BLA), the European Medicines Agency (EMA) has validated a marketing authorization application (MAA) for abicipar pegol. While the FDA is expected to give its decision in mid-2020, the same from EMA is expected in the second half of 2020.
The BLA and MAA filings were based on two phase III studies — SEQUOIA and CEDAR — evaluating abicipar compared with Novartis (NYSE:NVS) /Roche’s (OTC:RHHBY) Lucentis (ranibizumab) in treatment-naïve patients with nAMD. Data from the studies demonstrated that treatment with six or eight injections of abicipar resulted in similar efficacy for the primary endpoint (proportion of treated patients achieving stable vision at week 52) compared to 13 injections for Lucentis.
Allergan’s share price has risen 22.7% this year so far against the .
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