Eli Lilly and Co. Inc. said Friday the FDA has asked the drugmaker to conduct another clinical trial of its proposed pancreas drug before it resubmits an application to have the drug approved for sale.
The request comes three months after a Food and Drug Administration panel voted 7-4 to not recommend approval of the drug, known generically as liprotamase.
At the time, the panel recommended that Lilly be required to conduct additional studies of the drug.
Liprotamase is designed to treat exocrine pancreatic insufficiency — a shortage of a pancreatic enzyme that aids in digestion. The condition is usually seen in patients with cystic fibrosis or chronic pancreatitis or those who have undergone surgery to remove part of the pancreas.
Indianapolis-based Lilly acquired the drug as part of its acquisition of Alnara last summer.
The company said Friday it is committed to working with the FDA and the cystic fibrosis community to make the treatment option available to patients.
Its shares ended the regular session up 26 cents to $36.01.