The FDA’s Gastrointestinal Drugs Advisory Committee (GDAC) has voted to recommend non-approval of Eli Lilly’s Solpura (liprotamase), a non-porcine pancreatic enzyme replacement therapy, currently under Agency review for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and pancreatectomy.

During the meeting, the GDAC had questions about the degree of efficacy of Solpura and recommended that additional studies be conducted prior to considering approval of Solpura for EPI.

Lilly stated that it 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 NDA. The company remains confident in the clinical trial data package submitted to the Agency in support of the Solpura application. The product was originally developed by Alnara Pharmaceuticals, which Lilly acquired in 2010.

Statement From Lilly on FDA Advisory Committee Recommendation Regarding Liprotamase New Drug Application for Treatment of Exocrine Pancreatic Insufficiency

Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee voted today to recommend non-approval of liprotamase, a non-porcine pancreatic enzyme replacement therapy (PERT), currently under FDA review for the treatment of exocrine pancreatic insufficiency (EPI).

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.

“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.

Source: Key Pharma News

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