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CF Drug Hits Hurdle in FDA Approval Process

January 12, 2011

An advisory panel of the U.S. Food & Drug Administration (FDA) said today it did not have sufficient clinical trial data to recommend approval of liprotamase, a non-porcine pancreatic enzyme therapy for the treatment of cystic fibrosis. The panel also had questions about the degree of efficacy of the drug.

As part of the drug evaluation process, the FDA convened an advisory committee to provide input to the agency on liprotamase, as it does for other drugs.

At today’s meeting, data on liprotamase were presented by the FDA and by Eli Lilly and Company, which is developing the drug.

“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, in a company press statement.

Said Robert J. Beall, Ph.D., president and CEO of the CF Foundation: “We look forward to FDA’s final decision and recommendations regarding this drug. We will work with all parties to ensure that safe and effective new drugs are available to CF patients.” 

The FDA is expected to rule on liprotamase late this spring.

Read Eli Lilly’s full press statement.

The Cystic Fibrosis Foundation is an accredited charity of the Better Business Bureau.