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FDA rejects Lilly enzyme replacement

The US Food and Drug Administration has declined to approve Lilly's marketing application for liprotamase pancreatic enzyme replacement therapy as a treatment of exocrine pancreatic insufficiency

The US Food and Drug Administration (FDA) has declined to approve Lilly's marketing application for liprotamase pancreatic enzyme replacement therapy as a treatment of exocrine pancreatic insufficiency, a condition associated with cystic fibrosis (CF) and pancreatectomy in which patients cannot properly digest and absorb nutrients.

In a complete response letter (CRL) issued to the company, the FDA said that it would require an additional clinical trial before Lilly could resubmit the application.

"Lilly is looking forward to further discussion with the FDA to address the items outlined in the letter and provide the requested information as quickly as possible," said Eiry Roberts, VP-autoimmune, bone-muscle-joint, liprotamase product development.

Lilly's 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.

The FDA's decision on the product is in line with the advice of an advisory committee that voted in mid-January to recommend that the agency deny approval of the marketing application in its current form. The Gastrointestinal Drugs Advisory Committee voted 7-to-4 (with one abstention) against recommending approval and suggested that the FDA require additional studies, which the panel members indicated should include head-to-head trials against existing porcine-derived products.

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 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.

18th April 2011

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