Lilly/Alnara's CF drug candidate Solpura rejected by FDA advisory; Public Citizen seeks to stop further trials

US drug major Eli Lilly (NYSE: LLY) says that the US Food and Drug Administration’s Gastrointestinal Drugs Advisory Committee has voted by nine to three that clinical data submitted to support the New Drug Application for approval of Solpura (liprotamase) did not provide "substantial evidence of the efficacy"  and voted not to recommend approval of the drug, a non-porcine pancreatic enzyme replacement therapy (PERT), currently under the agency’s review for the treatment of exocrine pancreatic insufficiency (EPI), such as cystic fibrosis.

During the meeting, the committee had questions about the degree of efficacy of liprotamase and recommended that additional studies be conducted prior to considering approval of liprotamase for EPI. The drug is being developed by Lilly’s wholly-owned subsidiary Alnara Pharmaceuticals, which it acquired for an undisclosed sum last year, though reportedly this was around $380 million (The Pharma Letter July 5. 2010)

"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, vice president, autoimmune, bone-muscle-joint, liprotamase product development, at Lilly, adding: "We remain confident in the clinical trial data package submitted to the FDA in support of the liprotamase application."