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An advisory panel of the U.S. Food & Drug Administration (
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.
The Cystic Fibrosis Foundation has increased its award to Arcturus Therapeutics to up to $15 million to develop a mutation-agnostic therapy for people with cystic fibrosis.
Cystic Fibrosis Foundation Therapeutics Inc. will award up to $1.7 million to Alaxia SAS to test the safety of a potential inhaled therapy that may fight drug-resistant bacteria that infect people with cystic fibrosis
On September 16, 2008, the U.S. Food and Drug Administration (