FDA Issues Complete Response Letter to Biodel New Diabetes Drug Application

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) requesting additional information regarding Biodel Inc.’s new drug application (NDA) for Linjeta a more-rapid-acting human insulin injection for the treatment of type 1 and type 2 diabetes.

The CRL stated that the FDA’s review cycle is complete and that the application cannot be approved in its present form.The CRL included comments related to clinical trials, statistical analysis and chemistry, manufacturing and controls.

Biodel plans to contact the FDA within the coming weeks to request a meeting to discuss the company’s next steps and requirements for approval of Linjeta(TM).

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It is worth noting that this is not the same as a denial; rather it impacts a limited segment of the trial population conducted in India where some blood samples were compromised by excessive heat.  In a statement, the company said the “decision to exclude Indian trial data for the Type 1 study “was post-hoc and therefore not sufficient for establishing conclusive evidence of efficacy”, however, the company was not planning to begin marketing Linjeta until 2011 anyway; now the question is WHEN in 2011.  However, the pipeline for this company still looks very attractive and it could be acquisition… Read more »

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