FDA Issues Complete Response Letter to Allergan, Molecular Partners for Ocular Therapeutic BLA

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The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.

Allergan, an AbbVie company, and Molecular Partners, a clinical-stage biotechnology company specializing in a new class of custom-built protein therapeutics known as designed ankyrin repeat protein (DARPin) therapeutics, announced on June 26, 2020 that FDA has issued a complete response letter (CRL) to the biologics license application (BLA) for Abicipar pegol, a novel, investigational DARPin therapy for patients with neovascular (wet) age-related macular degeneration (nAMD).

The CRL indicates that the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of nAMD. AbbVie plans to meet with the agency to discuss their comments and determine next steps.

"We continue to believe in the need for treatment options that provide patients with reliable vision gains and less frequent dosing for the treatment of nAMD," said Michael R. Robinson, MD, vice-president, global therapeutic area head, Ophthalmology, AbbVie, in a company press release. "We are committed to working with [FDA] to determine the appropriate next steps for Abicipar pegol."


Source: AbbVie