FDA approves three Takeda diabetes drugs; expands use of Novartis' Gleevec and Pfizer's Prevnar 13

In what was a busy news day for the US Food and Drug Administration, the agency on Friday approved three new related products from Japan’s largest drugmaker, Takeda Pharmaceuticals (TYO: 4502), for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin), Kazano (alogliptin and metformin hydrochloride) and Oseni (alogliptin and pioglitazone) tablets.

Alogliptin is a new active ingredient, while metformin and pioglitazone are already FDA-approved for the management of type 2 diabetes. As the most common form of the disease, type 2 diabetes affects about 24 million people and accounts for more than 90% of diabetes cases diagnosed in the USA. The fixed-dose combination therapy alogliptin/pioglitazone suffered a setback last year, when the FDA issued another complete response letter (a first rejectioin came in 2009) further delaying approval of the drug (The Pharma Letter April 26, 2012).

Clearance of the three new products will provide Takeda with a new revenue source as it deals with the patent expiry of its blockbuster diabetes drug Actos (pioglitazone) which, in the fiscal year to March 2011, generated sales of $4.5 billion, around 27% of the firm’s total sales. Nesina faces fierce competition from a number of DPP-4 inhibitors already on the market, led by Merck & Co's Januvia (sitagliptin) as well as Bristol-Myers Squibb/AstraZeneca’s Onglyza/ Kombiglyze (saxagliptin) and Novartis’ Galvus (vildagliptin).