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Takeda files diabetes combination product in US

Seeks FDA approval for a combination of alogliptin and metformin

Takeda Pharmaceutical has filed for US approval for a fixed-dose combination therapy for type II diabetes that combines alogliptin with metformin in a single tablet.

Alogliptin is a selective dipeptidyl peptidase IV inhibitor that is already under review by the FDA as a single-agent therapy and in a combination with Takeda's thiazolidinedione drug Actos (pioglitazone), and was first submitted for approval in 2007.

Earlier this month, the agency said it had postponed the deadline for its decision on the first two formulations from January 25 to April 25, 2012. It had already turned down the applications in 2009 on grounds that Takeda needed to conduct an additional cardiovascular safety trial with the drug in order to bring its application into line with its 2008 guidelines for anti-diabetic therapies.

Alogliptin is already on the market in Japan, where it is marketed as Nesina, having been approved there in April 2010, but Takeda is a late-entrant to the DPP-IV inhibitor market which is currently dominated by Merck & Co's Januvia (sitagliptin) with sales of nearly $850m in the third quarter. Others in the class include Bristol-Myers Squibb/AstraZeneca's Onglyza (saxagliptin) and Novartis' Galvus (vildagliptin).

For patients diagnosed with type II diabetes, metformin monotherapy is the usual first-line therapy in addition to diet control and exercise, so a fixed-dose combination of a new anti-diabetic agent with metformin is a logical way to convert patients to a new regimen.

Merck already has a metformin combination product on the market called Janumet which brought in $350m in third-quarter revenues, so once again Takeda is playing catch up with its latest combination.

The drugmaker has high hopes for the alogliptin/pioglitazone combination, however, given that other drugs in the thiazolidinedione class are having their use restricted.

GlaxoSmithKline's Avandia (rosiglitazone) has been taken off the US market and had its indications narrowed in the US, for example, leaving Actos as the dominant product in the class.

Thomas Strack, vice president of Takeda's Global R&D Center in the US, said the latest submission reflects the company's commitment to offer patients with type II diabetes a range of therapeutic options.

"The worldwide incidence of type II diabetes continues to expand at an alarming rate and we continue our research into additional medications to treat these patients," he added.

24th November 2011

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