Patients’ Parents Upset By FDA Panel’s Rejection of Lilly/Alnara’s Cystic Fibrosis Drug

▤ Summary

Last week an FDA advisory panel shot down Eli Lilly’s (NYSE:LLY) enzyme therapy for cystic fibrosis that has deep roots in the Boston area. And two parents of children with cystic fibrosis, a genetic disease that typically requires people to take such treatments, say they feel like the regulators got this one wrong. Cystic fibrosis, which is known for causing a buildup of thick mucus in the lungs that makes it hard to breathe, also affects people’s digestion and their ability to absorb sufficient nutrients to maintain their weight. Liprotamase—the Lilly drug that it picked up through its buyout of Cambridge, MA-based Alnara Pharmaceuticals for as much as $380 million last summer—-is intended to provide certain pancreatic enzymes that patients with the disease and other conditions need to gain nutrition from foods. The agency’s staff also noted in its analysis issued last week that liprotamase scored lower in a measure of fat absorption than the existing supplements made with pig enzymes.

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