Regeneron Gets FDA Response Letter on Aflibercept 8 Mg Application, Says Issue Involves Third-Party Filler
28 June 2023 - 5:52AM
Dow Jones News
By Stephen Nakrosis
Regeneron Pharmaceuticals said it received a complete response
letter from the Food and Drug Administration for its aflibercept 8
mg biologics license application, adding the letter involves
inspection findings at a third-party filler.
Regeneron said "no issues with clinical efficacy or safety,
trial design, labeling or drug substance manufacturing were
identified in the CRL." The company also said it is committed to
working with the FDA and the third-party filler to bring
aflibercept 8 mg diabetic macular edema treatment to patients as
soon as possible.
Aflibercept 8 mg is being jointly developed by Regeneron and
Bayer AG.
Regeneron also reported two-year results from a trial of
aflibercept, which the company said "demonstrate durable vision
gains at extended dosing intervals in diabetic macular edema."
Two-year data from a trial for aflibercept 8 mg in wet
age-related macular degeneration are expected in the third quarter,
Regeneron said.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
June 27, 2023 15:37 ET (19:37 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
Regeneron Pharmaceuticals (NASDAQ:REGN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Regeneron Pharmaceuticals (NASDAQ:REGN)
Historical Stock Chart
From Jul 2023 to Jul 2024
