Takeda Pharmaceutical Co has suffered a major setback after regulators in the USA rejected its type 2 diabetes therapy alogliptin and the fixed-dose combination of the drug plus the Japanese drugmaker's Actos.
The company has received a second complete response letter from the US Food and Drug Administration regarding New Drug Applications for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor and the alogliptin/Actos (pioglitazone). The agency has requested additional data which Takeda believes it can supply from postmarketing data from outside the USA, as well as data from its ongoing clinical trial programme.
Thomas Harris, head of regulatory affairs at the Takeda global R&D centre in the USA, said that "we will immediately request a meeting with the FDA to determine the appropriate next steps and are committed to addressing outstanding issues". He added that "we remain confident in the benefit that alogliptin will bring".
It has been a tortuous path to approval. Takeda resubmitted two NDAs in July 2011, after receiving the first CRL in June 2009, which included interim data from a cardiovascular outcomes trial. The filing for alogliptin was originally submitted in December 2007, a year before the FDA issued fresh guidelines for diabetes drugs.
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 last year and is available as Liovel.