BioPharma Dive June 29, 2023
Dive Brief:
- An group of advisers to the Food and Drug Administration on Wednesday voted in favor of an experimental drug Ipsen Biopharmaceuticals has been developing for a rare bone disease known as fibrodysplasia ossificans progressiva.
- After an initial rejection last year, Ipsen submitted a new request that included new findings from an after-the-fact study analysis. The advisory committee voted 10-4 that the data show the drug is effective and 11-3 that the benefits of therapy outweigh the risks.
- Fibrodysplasia ossificans progressiva, or FOP, is an extremely rare and degenerative condition that causes muscle and connective tissue to turn into bone. The disease, estimated to affect less than 1,000 people worldwide, has no available treatments that can...
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