Takeda Pharmaceutical Co says that regulators in Europe have agreed to review its type 2 diabetes therapy alogliptin, a month after receiving a knockback from the US Food and Drug Administration.
The Japanese drugmaker has received confirmation of the acceptance of the submission of a marketing authorisation application from the European Medicines Agency for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor. The filing is based on trials involving more than 11,000 patients and several ongoing studies, including the EXAMINE trial which is evaluating cardiovascular endpoints following treatment with alogliptin.
The latter is being carried out to comply with criteria outlined in the FDA's December 2008 guidance for new antidiabetics. Final EXAMINE results are expected in 2015.
Last month, the FDA issued a second complete response letter for the drug and the fixed-dose combination of alogliptin plus Takeda's Actos (pioglitazone). The agency requested additional data which the company believes it can supply from postmarketing data from outside the USA, as well as data from its ongoing clinical programme.
Stuart Dollow, managing director, Takeda Global R&D Centre (Europe), said the acceptance of the alogliptin MAA submission is "a critical milestone" for the firm "as we continue investigating and expanding our therapeutic offerings for people with type 2 diabetes".
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.
The decision has also triggered a $10 million milestone payment to the USA's Furiex Pharmaceuticals. The latter receives royalties from Nesina and Liovel and is eligible to get them from sales in Europe, if approved.