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Cumberland liver failure drug rejected

The US Food and Drug Administration has rejected Cumberland Pharmaceuticals' bid to add a new indication to the uses of Acetadote

The Tennessee-based speciality drug company Cumberland Pharmaceuticals has received a complete response letter from the US Food and Drug Administration (FDA) rejecting its bid to add a new indication to the approved uses of Acetadote (acetylcysteine). The therapy has been marketed in the US since 2004 as the first injectable drug to treat acetaminophen overdose.

Cumberland had submitted a supplemental new drug application seeking approval for patients with non-acetaminophen induced acute liver failure, but the FDA determined that the application is not approvable in its current state.

Specifically, the agency said that while the data in the application show that liver failure patients with coma grade I/II had a numerically higher rate of transplant-free survival, there was not sufficient evidence of efficacy for the proposed indication of increasing survival in all patients with acute liver failure.

Cumberland said it intends to request a meeting with the FDA to gain clarification on the agency's concerns, and that it plans to continue to work toward approval of the drug for the new indication. "We continue to believe that the data and literature supporting Acetadote as a treatment for patients suffering from non-acetaminophen acute liver failure are extremely relevant to a critically ill patient population with few treatment alternatives," said CEO A J Kazimi.

The company filed the sNDA in March of this year and was granted a priority review. Under that review schedule, a decision from the FDA was originally due in August, but the agency pushed back the deadline to December, which was the first hint that approval might not be forthcoming.

The data in the application are from a study led by investigators at the University of Texas Southwestern Medical Center in which patients were grouped according to coma grade, with grade I representing the earliest stages of liver failure and grade IV representing the latest stage. Transplant-free survival was significantly higher at three weeks, one year and two years for patients in coma grades I and II receiving Acetadote than for those receiving placebo.

In October of this year, Cumberland submitted a US marketing application for second-generation formulation of the drug designed to replace the currently marketed product. The company expects a decision on that product in January 2011.

22nd December 2010

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