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Public Policy | Drug Pipeline | About the CF Foundation CF Foundation Drug Development Model Showcased at Congressional Briefing

The Cystic Fibrosis Foundation's successful business model was at the center of a congressional briefing in Washington, D.C., today, which focused on strategies for jump-starting drug development for rare diseases.

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About the CF Foundation | Public Policy | Clinical Trials Improving Access to Clinical Trials Act Takes Effect

A new law that allows patients with rare diseases to participate in clinical trials without losing eligibility for public health care benefits went into effect yesterday. The bill, known as the “Improving Access to Clinical Trials Act” (IACT), was championed by the Cystic Fibrosis Foundation and signed into law in October 2010.

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Research CF Drug Hits Hurdle in FDA Approval Process

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.

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