FDA Advisory Committee Rejects Eli Lilly's Lipromatase
Eli Lilly has announced the U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee recommended against the approval of liprotamase (Solpura), a non-porcine pancreatic enzyme replacement therapy (PERT).
Currently, there are no non-porcine PERTs on the market. Porcine-derived products include versions of pancrelipase, sold by Abbott Laboratories, Johnson & Johnson and Eurand (see today's Nycomed story).
The FDA Advisory Committee voted 9-3 that the data submitted did not provide substantial evidence of efficacy as a treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis, chronic pancreatitis, pancreatectomy or other conditions. The panel also voted 7-4 (with one abstention) as to whether liprotamase's risks outweighed its benefits, and recommended that additional studies be conducted prior to considering approval of liprotamase for EPI.
"We appreciate the feedback the committee has provided, and we will continue to work with the FDA to address the questions raised in the meeting as the agency moves toward a final decision on the application," said Eiry Roberts, M.D., Vice President, Autoimmune, Bone-Muscle-Joint, Liprotamase Product Development at Lilly. "We remain confident in the clinical trial data package submitted to the FDA in support of the liprotamase application."
The FDA is not required to follow the recommendation of its advisory committees.
PERT is a treatment involving the oral administration of pancreatic enzyme replacements, which include protease, amylase and lipase.
Patients with EPI cannot properly digest and absorb nutrients including fat, protein and carbohydrates. Causes of EPI include cystic fibrosis, chronic pancreatitis and pancreatectomy.
Cystic fibrosis affects approximately 30,000 children and adults in the United States and nearly 100,000 people worldwide. Approximately 90 percent of cystic fibrosis patients receive PERT.