Takeda Pharmaceutical Co is going to have to wait a bit longer to get US approval for its type 2 diabetes therapy alogliptin, and the fixed-dose combination of the drug plus the Japanese drugmaker's Actos.
The company says it has received notification from the US Food and Drug Administration that its review of alogliptin, and the combination of the latter and Actos (pioglitazone) will be delayed. A new Prescription Drug User Fee Act action date has been set for April 25, having been originally assigned for January 25.
Takeda gave no details about the reasons for the delay and David Recker, head of clinical science at the firm's global R&D centre in the USA, said that "we will work closely with the FDA to determine the appropriate next steps". He added that "we are dedicated to continuing our efforts to bring these important therapies to market in the USA."
Takeda resubmitted two New Drug Applications to the FDA 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.
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 in Japan in July this year and is available as Liovel.