US regulator still doesn’t buy abicipar

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Allergan had worked hard to make its wet age-related macular degeneration project abicipar pegol approvable, but it was not to be. Today the US FDA issued a complete response letter for the Darpin anti-VEGF molecule, citing intraocular inflammation concerns, which make for an unfavourable risk-benefit profile. The project, developed with Molecular Partners, was to have challenged Lucentis and Eylea in wet AMD, but intraocular inflammation emerged as a serious side effect in phase III. Undeterred, a new formulation was taken into another study, Maple, and while this showed lower rates of inflammation – 8.9% versus around 15% in the earlier trials – these were still above the less than 1% with Lucentis and Eylea. How to proceed now is of course a problem for Abbvie, which completed its takeover of Allergan last month. Given the looming entry of biosimilar versions of Lucentis and Eylea it seems likely that for Abbvie abicipar was nice to have rather than a major attraction even before the latest setback, and sellside consensus reflected modest expectations.

Note: this forecast, via EvaluatePharma, predated today's US complete response letter, and assumed a December 2020 launch.

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