FDA Rejects Abicipar Pegol Application from Allergan, Molecular Partners
June 26 2020 - 7:36AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 26, 2020 07:21 ET (11:21 GMT)
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