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news.The US Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee has voted against recommending Eli Lilly's enzyme replacement therapy (PERT), Liprotamase for approval.'
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Lilly‘s Liprotamase is currently under FDA review as a treatment for exocrine pancreatic insufficiency (EPI).
In the committee had questions about the degree of efficacy of Liprotamase and has recommended additional studies for Liprotamase prior to considering approval of the drug as a treatment for EPI.
Lilly Autoimmune, Bone-Muscle-Joint, Liprotamase Product Development, Autoimmune vice president Eiry Roberts said they appreciate the feedback the committee has provided, and they 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.
"We remain confident in the clinical trial data package submitted to the FDA in support of the Liprotamase application," Roberts said.