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Which Came First? Alogliptin Avoids Possible Exclusivity Dispute

 
• By Michael McCaughan

An unusual footnote in FDA’s approval letter for Takeda’s long-delayed diabetes medicine means that the company won’t have to worry about losing five-year exclusivity on the molecule.

You can forgive Takeda Pharmaceutical Co. Ltd. for perhaps feeling very little by way of gratitude when FDA granted approval to the type 2 diabetes agent alogliptin in January. After all, the company had been waiting more than five years: Takeda filed the NDA in 2007 — just in time for the drug to get caught in the suddenly rising bar for type 2 diabetes drugs in the wake of the Avandia controversy. Also see "Regulatory Risk and Business Development: Type 2 Diabetes Falls Out of Favor" - Pink Sheet, 1 October, 2008.

Indeed, of all the products affected by that flap, alogliptin arguably suffered the most (except for Avandia itself): while other...

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• By Francesca Bruce

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