Monday, January 28, 2013

USFDA Approves three new treatments for type 2 diabetes - Nesina (Alogliptin), Kazano (Alogliptin + Metformin) and Oseni ( and Alogliptin + Pioglitazone)

After being rejected twice, Takeda has eventually gained USFDA approval for its DPP-IV inhibitor - Alogliptin. Alogliptin (Nesina) will be the fourth DPP-IV inhibitor in the US, the other three being, Januvia, Onglyza and Tradjenta. 

The DPP-IV class of drugs currently take about  10 percent of the overall anti-diabetes market and is still growing in double digits. The future growth of the DPP-IV market would be shaped by the ongoing CV outcome studies. The first CV outcome study to report data would be SAVOR- TIMI 53, which is studying saxagliptin (Onglyza) as an add on to other diabetes medicines.
Along with Alogliptin monotherapy, two other fixed dose combination  of Alogliptin with metformin and pioglitazone  as well have been approved. This is for the first time a fixed dose combination of DPP-IV and a glitazone has been approved. Merck as well was conducting trials to get an FDC of Januvia and pioglitazone approved, but later withdrew the same, citing viability concerns.

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