U.S. FDA Panel Endorses Two Peptides for Compounding Amid Amgen’s Tavneos Appeal

Good morning. As the workweek resumes, here are some notable developments in the biotech sector.

A U.S. Food and Drug Administration advisory panel on Friday voted to permit compounding pharmacies to produce the peptides epitalon and semax, while narrowly rejecting a similar allowance for emideltide. STAT reports. The decision follows the panel’s earlier recommendation to allow pharmacies to manufacture four additional peptides, advancing Health and Human Services Secretary Robert F. Kennedy Jr.’s effort to broaden access to these unapproved compounds. Interest in peptides has grown in the United States, fueled by endorsements from social‑media influencers.

Amgen has submitted new data to the FDA in support of a hearing to contest the proposed withdrawal of its rare‑disease drug Tavneos from the U.S. market. Reuters notes. In April, the agency proposed withdrawing Tavneos, which treats a rare autoimmune disorder that damages blood vessels, citing insufficient evidence of effectiveness and inaccuracies in the original marketing application. Amgen disputes the FDA’s assessment, pointing to more than 70 real‑world studies involving over 2,200 patients that back the drug’s safety and efficacy.

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