Lilly’s Solpura Isn’t Ready for Approval, Panel Says
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Eli Lilly & Co. failed to win a U.S. advisory panel’s recommendation to introduce the first pancreatic enzyme that isn’t derived from pig parts.
The risks of Lilly’s Solpura don’t outweigh its benefits in patients with cystic fibrosis or other conditions that impede digestion, outside advisers to the Food and Drug Administration voted 7-4 today with one abstention. The panel also recommended during its meeting at the agency’s headquarters in Silver Spring, Maryland, that more studies be done on the drug’s safety and effectiveness.