FDA reviews interim access policy for compounded peptides as Enspryng label expands
The U.S. Department of Health and Human Services and the Food and Drug Administration have drafted a new interim access policy that would allow compounding pharmacies to use certain peptide drugs under specific conditions.
The draft policy is currently under review by the White House Office, and if approved it could provide a pathway for patients to obtain peptide therapies that are not otherwise commercially available.
In related news, the FDA is also considering a label expansion for the multiple sclerosis drug Enspryng, although details of the change were not disclosed in the briefing.
The briefing also mentioned updates from Microbiotica, Cyrano Therapeutics and Opus Genetics, but no further information was provided.
This writeup was produced by pharmadog from original reporting by Endpoints.
Original headline: “FDA considers interim access for compounded peptides; Enspryng's label expansion”
read at Endpoints ↗
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