FDA Rejects ITM Therapy; Hims & Hers Eyes Peptides
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- FDA rejected a radiopharmaceutical therapy from ITM Isotope Technologies Munich SE because of manufacturing issues, halting what would have been a competitor to Novartis in the emerging class of tumor-targeting radioactive treatments.
- ITM had anticipated approval and last month launched a new commercial division, Lumara Bio, to sell the drug.
- Hims & Hers plans to enter the peptides market before the end of the year, preparing to sell already-allowed compounds that patients seek for wellness and longevity benefits despite limited clinical evidence.
- FDA is weighing whether to loosen restrictions on seven different peptide compounds, after outside advisers at a hearing last month recommended easing production limits and expanding access.
Why it matters: The FDA rejected ITM's radiopharmaceutical not over efficacy but manufacturing, exposing production quality as the gating factor for a drug class meant to rival Novartis. Separately, Hims & Hers' planned peptides launch hinges on the FDA loosening rules on seven compounds, where outside advisers already tilted toward easing access.
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