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Lilly drug rejected by FDA advisory panel

An FDA advisory committee has voted to recommend against approval of Lilly's liprotamase pancreatic enzyme replacement therapy as a treatment of exocrine pancreatic insufficiency

An advisory committee to the US Food and Drug Administration (FDA) has voted to recommend that the agency deny approval of Lilly's liprotamase pancreatic enzyme replacement therapy as a treatment of exocrine pancreatic insufficiency, a condition associated with cystic fibrosis and pancreatectomy in which patients cannot properly digest and absorb nutrients.  

The orally delivered therapy differs from current products in that it is produced using recombinant technology rather than being porcine-derived. Porcine-derived pancreatic enzymes can vary in potency and stability. In addition, the Lilly drug has a lower pill burden than existing therapies.

However, the FDA's Gastrointestinal Drugs Advisory Committee voted 7-to-4 (with one abstention) against recommending approval and raised questions about liprotamase's efficacy. The committee recommended that the FDA require additional studies on the therapy, which would most likely include head-to-head trials against existing porcine-derived products.

The FDA is not required to follow the advice of its advisory committees, which are made up of experts from outside the agency, but it frequently does so.

Lilly said it remains confident in the data that was submitted to the FDA and will continue to work with the agency on the application. "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," Eiry Roberts, a Lilly vice president, said in a statement.  

Lilly acquired liprotamase when it bought the biotech company Alnara last July in a bid to enter the enzyme replacement therapy market. At the time of the acquisition, Alnara had already submitted the US marketing application for liprotamase, which is its lead product candidate.

Alnara licensed worldwide rights to the product from the Cystic Fibrosis Foundation Therapeutics following the completion of a phase III efficacy trial that found a statistically significant improvement in fat and protein absorption in CF patients who used the therapy. The study also showed promising results in improving overall nutritional status in patients.

Liprotamase is expected to be marketed in the US under the tradename Solpura if it is approved.

13th January 2011

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