Compounded GLP-1 drugs are often more affordable and easier to obtain than the brand-name medication Ozempic. However, some doctors state that these compounded versions carry serious risks for patients.
FDA Advisory Panel Decisions
A U.S. Food and Drug Administration (FDA) advisory panel recommended that compounding pharmacies be permitted to manufacture the peptides epitalon and semax.
The panel's decision on Thursday included recommendations for four other peptides, while it narrowly voted against the manufacturing of emideltide.
The recommendation brings U.S. Health and Human Services secretary Robert F. Kennedy Jr. one step closer to his mission of making these unapproved compounds more available for Americans.
Peptides have become increasingly popular in the U.S., driven by endorsements from social media influencers.
Amgen Challenges Tavneos Withdrawal
In April, the FDA proposed withdrawing Tavneos, a treatment for a rare autoimmune disease that damages blood vessels. The agency cited a lack of proven effectiveness and false statements in the original marketing application.
Amgen strongly disagrees with the FDA regarding the proposed withdrawal of Tavneos.
To challenge the proposal, Amgen submitted over 70 real-world studies involving more than 2,200 patients to support the drug’s safety and effectiveness.
Number of real-world studies submitted by Amgen to support Tavneos's continued market availability.