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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 today applauds the Food and Drug Administration's approval of Kalydeco™ (ivacaftor; previously known as VX-770), a major advance in the search for a cure for cystic fibrosis.
A $7.5 million research award will go to Southern Research to identify potential new drugs for people with rare CF mutations, known as nonsense mutations, Cystic Fibrosis Foundation Therapeutics Inc. announced today.
The Cystic Fibrosis Foundation celebrates the FDA's approval today of the lumacaftor/ivacaftor combination drug (Orkambi™) as an important advance for the cystic fibrosis community. Orkambi targets the underlying cause of the disease in people with two copies of the most common CF gene mutation.