Takeda Pharmaceutical Co will soon find out whether its lengthy bid to get US approval for the type 2 diabetes therapy alogliptin, and the fixed-dose combination of the drug plus the Japanese drugmaker's Actos, has been successful.
The US Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 25 for its review of alogliptin, and the combination of the latter and Actos (pioglitazone) in a single tablet. Takeda resubmitted two New Drug Applications to the agency in July, after receiving a complete response letter in June 2009.
The refiling included interim data from a cardiovascular outcomes trial, titled EXAMINE. The NDA for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor was originally submitted in December 2007, a year before the FDA issued fresh guidelines for diabetes drugs. Nevertheless the agency had rejected the drug saying existing data was not sufficient to meet requirements outlined in the new guidance.
The company seems particularly excited about the prospects for the combo. David Recker, head of clinical science at Takeda Global R&D Center, noted that it produced "significant improvements in glycaemic control" compared to individual monotherapy in Phase III trials. If approved, alogliptin/pioglitazone will be the first type 2 diabetes therapy in the USA to combine a DPP-4 inhibitor with a thiazolidinedione in a single tablet".
Alogliptin was approved in April 2010 by the Japanese Ministry of Health, Labour, and Welfare and is sold under the brand name Nesina. The fixed-dose combination got the green light on home soil in July this year and is available as Liovel.
When asked by PharmaTimes World News, Takeda did not comment about the take-up for Nesina and Liovel, nor about how the firm intends to compete with Merck & Co's DPP-4 inhibitor Januvia (sitagliptin) and Janumet (sitagliptin plus metformin), which are well-established. Indeed, third-quarter sales of the drugs reached $846 million (+41%) and $350 million (+42%), respectively.