Eli Lilly has suffered a bit of a setback after advisors to the US regulator voted against recommending Solpura for approval as a non-porcine pancreatic enzyme replacement therapy.
Lilly is hoping that Solpura (liprotamase), developed by its Alnara Pharmaceuticals subsidiary, will be the the first treatment not based on pig enzymes to get the green light to help a subset of pancreatic patients digest their food. Porcine-derived products already on the market include versions of pancrelipase, sold by Abbott Laboratories, Johnson & Johnson and Eurand (see today’s Nycomed story).
However, the US Food and Drug Administration’s Gastrointestinal Drugs 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 Solpura’s risks outweighed its benefits, and recommended that additional studies be conducted prior to considering approval of liprotamase for EPI.
Eiry Roberts, head of liprotamase development at Lilly, said “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”. She added that “we remain confident in the clinical trial data package”.
