Allergan's Filings for Abicipar Pegol Accepted in U.S/Europe
Allergan plcAGN 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 NVS /Roche’s 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 industry ‘s decrease of 6.5%.
Please note that Regeneron Pharmaceuticals’ REGN blockbuster anti-VEGF drug Eylea (aflibercept) Injection is another popular drug approved to treat patients with nAMD. However, abicipar, with its quarterly dosing regimens, has the potential to reduce patient burden by lowering the frequency of injections while maintaining vision gains.
In April, Allergan announced data from another study on abicipar, MAPLE, a 28-week open-label study which used a modified manufacturing process to test an optimized 12-week formulation of abicipar in nAMD patients. Following the improved manufacturing process, it was observed that the incidence of intraocular inflammation (IOI) in the study was lower than SEQUOIA and CEDAR studies. In the MAPLE study, the reported incidence of IOI was 8.9%, which was less than around 15% observed in the SEQUOIA and CEDAR studies. If abicipar pegol is later approved as a fixed 12- week anti-VEGF treatment for nAMD based on MAPLE data, it will reduce the treatment burden for these patients.
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