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Biodel diabetes drug rejected

Biodel's marketing application for diabetes treatment Linjeta cannot be approved in its current form according to the US FDA

The US Food and Drug Administration (FDA) has informed Biodel that the company's marketing application for Linjeta, a fast-acting insulin product for the treatment of type 1 and type 2 diabetes, cannot be approved in its current form.

In a complete response letter issued to the company, the FDA said that at least two new clinical studies would be needed before the drug could be approved. Linjeta, which was previously known as Viaject, is the company's lead product candidate.

The drug, which is intended to be used at mealtimes, is comprised of commercially available recombinant human insulin plus a proprietary formulation of ingredients designed to promote very rapid absorption that closely mirrors the effects of naturally produced insulin.

The US marketing application included two six-month phase III studies comparing the effects of Linjeta to Lilly's Humulin, the leading recombinant human insulin, in patients with type 1 and type 2 diabetes. Biodel also submitted interim results from 18-month safety extension trials for patients who completed the pivotal phase III trials.

However, complications with a phase III trial in type I diabetes conducted in India left Biodel with less data to include in the US application than the company and the regulators had been anticipating. "The FDA stated (in the complete response letter) that, in the type 1 trial analysis, excluding data from India was post-hoc and therefore not sufficient for establishing conclusive evidence of efficacy," Biodel reported.

Regarding the study in type 2 diabetes, "the FDA acknowledged that non-inferiority was established in the completer population but stated that non-inferiority was not established in the intent-to-treat population because the agency did not consider a post-hoc modification of the statistical model as establishing conclusive evidence of efficacy."

The federal agency also said it will require additional proof of the product's safety compared to Humulin. "Unequivocal non-inferiority needs to be achieved in order to compare the risk of hypoglycaemia," Biodel said.

To fill the gaps in the application, the FDA is asking for two new phase III clinical trials, one in patients with type 1 diabetes and the other in patients with type 2 diabetes, as well as additional data related to product stability and manufacturing.

Biodel said it will request to meet with the agency as soon as possible to discuss next steps.

1st November 2010

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