Allergan, a unit of AbbVie ABBV, and Switzerland-based Molecular Partners announced that the FDA has issued a complete response letter (“CRL”) to the biologics license application (“BLA”) seeking approval for abicipar pegol. The companies evaluated abicipar pegol, a new class of custom-built protein therapeutics — DARPin, as a potential treatment for neovascular (wet) age-related macular degeneration (nAMD).
The CRL stated that the rate of intraocular inflammation observed following administration of the candidate showed an unfavorable benefit-risk ratio in nAMD patients. AbbVie is planning to discuss the CRL with the FDA to determine the appropriate next steps for abicipar pegol.
A regulatory application seeking approval for abicipar pegol similar indication is also under review in Europe. A decision is expected in the second half of 2020.
Please note that AbbVie completed the acquisition of Allergan last month for a cash-and-stock transaction approximately valued at $63 billion.
AbbVie share price has risen 9.5% this year so far against the industry’s decrease of 3.8%.
Regulatory filings for abicipar pegol were filed based on two phase III studies — SEQUOIA and CEDAR — which evaluated abicipar pegol compared with Novartis NVS/Roche’s RHHBY Lucentis (ranibizumab) in treatment-naive nAMD patients. Data from the studies had demonstrated that treatment with six or eight injections of abicipar pegol resulted in similar efficacy for the primary endpoint (proportion of treated patients achieving stable vision at week 52) compared to 13 injections for Lucentis.
Please note that Regeneron Pharmaceuticals' REGN blockbuster anti-VEGF drug Eylea (aflibercept) injection is approved to treat patients with nAMD. However, abicipar pegol, with its quarterly dosing regimens, has the potential to reduce patient burden by lowering the frequency of injections while maintaining vision gains.
However, the path forward for abicipar pegol will be decided following AbbVie’s meeting with the FDA.
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