FDA Targets Compounded Weight-Loss Drugs: Impact on Novo Nordisk and Eli Lilly

The FDA proposes excluding Novo Nordisk and Eli Lilly's weight-loss drugs from active ingredients used by outsourcing facilities for compounded medicines. This move aims to restrict unauthorized drug versions affecting sales. Shares of both companies saw significant increases. The proposal focuses on semaglutide and tirzepatide, with no clinical need found for compounding from bulk substances.

The U.S. Food and Drug Administration has taken a decisive step to exclude weight-loss drugs by Novo Nordisk and Eli Lilly from ingredients available to outsourcing facilities for compounded medicines.

This proposal, if finalized, limits compounding of these drugs to scenarios like drug shortages, supporting efforts to curtail unauthorized versions impacting sales. Stocks for Novo and Lilly surged, rising 6% and over 8% respectively, following the announcement.

The FDA has been eyeing compounded drugs, aiming to restrict unapproved alternatives. The agency found no clinical need for outsourcing facilities to compound from the bulk substances of semaglutide and tirzepatide, as part of a new regulatory measure.