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Approval of Bydureon denied by FDA

The US Food and Drug Administration (FDA) has withheld approval of Eli Lilly's Bydureon, the once-weekly form of the type 2 diabetes drug Byetta

The US Food and Drug Administration (FDA) has withheld approval of Eli Lilly's Bydureon, the once-weekly form of the type 2 diabetes drug Byetta (exenatide). It has asked for clarification on the drug's manufacturing process, finalisation of the product labelling and a risk management strategy.

The agency, however, has not asked for new tests or information related to quality-control violations identified in an inspection made at a US manufacturing facility in December 2009, which have been "addressed" the drugmaker said.

Lilly markets Byetta outside the US and co-markets it with Amylin in the US. The drug was developed by Amylin and the technology enabling it to be used in a longer-acting form was developed by Alkermes.

The companies submitted the marketing application for Bydureon in May 2009, which was supported by results comparing the once-weekly drug to the twice-daily product Byetta. Bydureon also performed well against other diabetes therapies including Takeda's Actos, sanofi-aventis' Lantus and Merck's Januvia.

Orville Kolterman, senior vice president of research and development at Amylin, remarked that the companies will submit responses to the FDA within the "next few weeks".

Byetta has annual sales of around $700m and is used to treat type 2 diabetes. Analysts forecast that sales of Bydureon if approved could reach $2bn by 2015.

16th March 2010

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