Pierre Fabre aligns with FDA on resubmission of Ebvallo cell therapy
Pierre Fabre Laboratories announced that it has reached an agreement with the U.S. Food and Drug Administration on a new path for its cell therapy Ebvallo, which had been rejected twice.
The FDA will accept data from a single-arm study that uses an appropriate historical control as sufficient for a resubmission. Updated results will come from the ongoing Phase 3 trial with additional patients and longer follow-up.
The move follows criticism that the agency previously backtracked on its stance. Separate industry news included Argenx's CEO change and Blackstone Life Sciences' $250 million investment in biotech.
This writeup was produced by pharmadog from original reporting by BioPharma Dive.
Original headline: “FDA to reevaluate spurned cell therapy; Under-the-skin Leqembi review extended”
read at BioPharma Dive ↗
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