ImmuPharma Says US Partner Hasn't Had Written Response From FDA Over Lupuzor

By Joe Hoppe

ImmuPharma PLC said Wednesday that its U.S. partner for its Lupuzor lupus treatment hasn't yet received a written response concerning development and review from the U.S. Food and Drug Administration, due to general delays.

The London-listed biopharmaceutical company had said on July 7 that partner Avion Pharmaceuticals has received a Type C meeting confirmation from the FDA. It said then that the statement of purpose, objectives and proposed agenda of the meeting have already been agreed on, as has the option to provide written responses, rather than face-to-face meetings.

A Type C meeting concerns the development and review of certain products.

The FDA then had agreed to provide a written response by Aug. 29. As of Tuesday, Avion hasn't yet received a written response.

ImmuPharma said it was in close contract with Avion and has been advised that the FDA is experiencing general delays in meeting response dates, and that this isn't specific to Avion or the meeting for Lupuzor.

Write to Joe Hoppe at [e-mail]

(END) Dow Jones Newswires

08-31-22 0250ET