Once-daily Janumet finally gets US FDA OK, boosting Merck's diabetes franchise
This article was originally published in Scrip
Merck & Co's once-daily combination diabetes treatment Janumet XR has now received US approval a year after the acceptance of the NDA and following a complete response letter last summer.
The extended-release combination of metformin and its DPP-IV inhibitor sitagliptin will be available in the next few weeks, and will be priced comparably with both the immediate-release combination product Janumet and the single sitagliptin product Januvia, Merck said.
The complete response letter related to the resolution of pre-approval inspection issues and followed the acceptance of the NDA in January 2011 (scripintelligence.com, 2 August 2011).
Once on the market it will finally be able to compete with AstraZeneca/Bristol-Myers Squibb's similar product Kombiglyze XR, which contains the DPP-IV inhibitor saxagliptin (Onglyza) also with metformin. This was launched in November 2010, giving it a substantial head-start over Janumet XR. AstraZeneca has just reported full-year 2011 revenues for its Onglyza collaboration with BMS at $211 million, of which $156 million was from the US. It said its combined franchise market share reached 16.5% in December 2011.
But Merck is already more strongly positioned in this market. It has just announced that worldwide sales of its Januvia/Janumet franchise grew by 40% to $1.3 billion in the fourth quarter of 2011 driven by growth in all regions. The combined franchise had sales of $4.7 billion for the full year of 2011, again an increase of 40%.
But the DPP-IV inhibitor/metformin combination market has just been further complicated by the US FDA approval earlier this week of Boehringer Ingelheim and Lilly's Jentadueto, a combination of the DPP-IV inhibitor Tradjenta (linagliptin) and metformin. This product is taken twice daily and is due to be launched within a month (scripintelligence.com, 1 February 2012).