Takeda was celebrating at the end of last week after the FDA granted approval to three of its diabetes drug candidates.
The US agency approved Takeda’s DPP-4 inhibitor Nesina (alogliptin) – along with two fixed-dose combination products Oseni (alogliptin and pioglitazone) and Kazano (alogliptin and metformin) – for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.
The alogliptin franchise enters an increasingly crowded DPP-4 inhibitor market, although Oseni is the first product on the US market to include a DPP-4 inhibitor in combination with a thiazolidinedione (TZD) in a single tablet.
The Japanese pharma company said it intends to launch all three drugs in the US in the summer, when they will join other DPP-4 inhibitors such as Merck & Co’s Januvia (sitagliptin), Bristol-Myers Squibb/AstraZeneca’s Onglyza (saxagliptin), Lilly/Boehringer Ingelheim’s Trajenta (linagliptin) and Novartis’ Galvus (vildagliptin).
News of the approval is a major boost for Takeda, which has been under pressure since it lost patent protection of diabetes blockbuster Actos (pioglitazone) last August and faced two rejections by the FDA as it sought to bring alogliptin through to market.
The agency sought more information on the drug’s cardiovascular safety and Takeda started an additional trial called EXAMINE to investigate this. Although not due to generate final results until 2015, the company has filed interim data with the agency to support alogliptin’s marketing application.
The new franchise has a major hole to fill, given that Actos reached sales of almost $4.5bn at its peak, accounting for more than a quarter of Takeda’s overall revenues, and looks set to experience a major fall-off in revenues in 2012. Analysts have suggested that Nesina and its sister products could achieve sales of up to $2bn at peak.
The agency is asking for five postmarketing studies for alogliptin as a condition of approval, including a cardiovascular outcomes trial and a study to monitor for liver abnormalities and serious cases of pancreatitis.
Alogliptin was approved as Nesina in Japan in 2010 and was submitted for approval in the EU last May.