FDA Panel Backs Epitalon, Semax; Rejects Emideltide
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- FDA advisory panel recommended Friday that compounding pharmacies be allowed to manufacture peptides epitalon and semax, but narrowly voted against manufacturing emideltide.
- The same panel voted Thursday to recommend allowing pharmacies to make four other peptides, bringing HHS Secretary Robert F. Kennedy Jr. one step closer to making these unapproved compounds more available to Americans.
- Peptides have grown increasingly popular in the U.S., driven by endorsements from social media influencers.
- Amgen submitted new evidence to the FDA seeking a hearing to challenge the proposed withdrawal of its rare-disease drug Tavneos, including more than 70 real-world studies involving over 2,200 patients supporting the drug's effectiveness and safety.
- In April, the FDA proposed withdrawing Tavneos — which treats a rare autoimmune disease that damages blood vessels — citing a lack of proven effectiveness and false statements in the original marketing application.
Why it matters: Implementing the panel's recommendations would let compounding pharmacies produce epitalon and semax without traditional FDA approval, widening access to compounds whose U.S. demand is fueled by social media influencers. Separately, Amgen's submission of over 70 real-world studies covering 2,200 patients sets up a potential hearing on reversing the FDA's April proposal to withdraw Tavneos.
