Takeda Pharmaceutical Co is celebrating after regulators in the USA finally gave the green light to the company's Nesina, plus two combinations of the drug, as treatments for type 2 diabetes.
The US Food and Drug Administration has approved Nesina (alogliptin) as well as a fixed-dose combination (of the latter and Takeda's Actos (pioglitazone), which will be marketed as Oseni. The agency also gave the thumbs-up to Kazono (alogliptin/metformin).
The FDA noted that Nesina, a selective dipeptidyl peptidase IV (DPP-4) inhibitor, was demonstrated to be safe and effective in 14 clinical trials involving about 8,500 patients. Data showed reductions in glycosylated hemoglobin (HbA1c) of 0.4%-0.6% compared with placebo after 26 weeks of use.
However, the agency is requiring five postmarketing studies for Nesina, including a cardiovascular outcomes trial and an "enhanced pharmacovigilance programme to monitor for liver abnormalities, serious cases of pancreatitis and severe hypersensitivity reactions". It is also demanding additional studies on Kazano, which carries a boxed warning for lactic acidosis, and Oseni, the label for which contains a warning for heart failure associated with pioglitazone.
Indeed the road to approval in the USA has been a bumpy one. Last April, Takeda received a second complete response letter from the FDA for Nesina and Oseni, both of which have been available in Japan for some time now. Now Nesina will enter the highly competitive DPP-4 inhibitor market which is dominated by Merck & Co's Januvia (sitagliptin).
The approvals are also good news for the USA's Furiex Pharamceuticals, which was involved in the development of alogliptin. The firm is entitled to receive a $25 million milestone payment as a result of the thumbs-up, plus royalties.