Takeda Pharmaceutical Company has received approval from the US Food and Drug Administration for Nesina, plus two combinations of the drug, as treatments for type 2 diabetes.

Nesina, whose generic name is alogliptin, along with Kazano (alogliptin and metformin hydrochloride) and Oseni (alogliptin and pioglitazone), will be used as adjuncts with diet and exercise to control blood sugar levels in patients with the disease.

The clearance has been a long time coming for Takeda - the FDA has delayed the approval of Nesina at least twice since 2009 and the pharmaceutical company carried out 14 trials involving 8,500 patients before the drug was deemed safe and effective.

But the FDA still requires five postmarking studies for Nesina: a cardiovascular outcomes trial; a pharmacovigilance programme to monitor for liver abnormalities, serious cases of pancreatitis,and severe hypersensitivity reactions; and three pediatric studies including a dose-finding study and two safety and efficacy studies.

The approvals are good news for Takeda, as its best-selling diabetes drug Actos lost patent protection in August.

Today, the Japan-based company rose 1.4% to JPY4,615 in Tokyo trading, the highest since December 2008, reports Bloomberg.

Takeda president Douglas Cole said; "Takeda is pleased with the FDA approval of Nesina, Oseni and Kazano for the treatment of type 2 diabetes, a therapeutic category in which we have more than 20 years of clinical and patient experience.

"Millions of people are affected by diabetes and, as a leader in the diabetes arena, Takeda is dedicated to working to advance patient care and helping to meet the needs of this growing patient population."