FDA Rejects Abicipar Pegol Application from Allergan, Molecular Partners

By Colin Kellaher

AbbVie Inc. on Friday said the U.S. Food and Drug Administration has indicated that it won't approve a biologics license application from its Allergan unit and Molecular Partners AG for Abicipar pegol in patients with wet age-related macular degeneration.

The North Chicago, Ill., biopharmaceutical company said the FDA issued a complete response letter indicating that the rate of intraocular inflammation observed following administration of Abicipar pegol resulted in an unfavorable benefit-risk ratio.

AbbVie said it plans to meet with the FDA to discuss the agency's comments and to determine the appropriate next steps for Abicipar pegol, an investigational DARPin therapy.

Molecular Partners, a Zurich clinical-stage biotechnology company, is developing a new class of custom-built protein therapeutics known as DARPin therapeutics. The company formed a partnership with Allergan in 2011 to develop products aimed at treating retinal diseases.

Shares of Molecular Partners tumbled 37%, to CHF14.16 ($14.93), in Friday trading.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

June 26, 2020 07:21 ET (11:21 GMT)

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