Januvia sitagliptin regulatory update

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) issued a preliminary benefit assessment saying that a non-fixed combination of Merck's Type II diabetes drug Januvia sitagliptin and metformin had varying degrees of additional benefit, depending on the specific patient population, over sulfonylurea and metformin. IQWiG said that the combination has a "marginal" additional benefit over sulfonylurea and metformin in patients for whom a near-normal blood sugar level is the therapeutic goal. IQWiG also said that Januvia plus metformin has "major" additional benefit over the sulfonylurea glipizide in men for whom a near-normal blood sugar level is the therapeutic goal, while the combination has an "unquantifiable" additional benefit over glipizide in women for whom a near-normal blood sugar level is the therapeutic goal. IQWiG said that in a 2-year study evaluating Januvia plus metformin, 1 man died in the Januvia arm, while 8 men died in the glipizide arm.

IQWiG said the product had "no additional benefit" in 4 other combinations - Januvia as monotherapy, Januvia plus sulfonylurea, Januvia plus metformin and sulfonylurea and Januvia plus insulin with or without metformin - because the company did not submit data or data submitted by the company was not "relevant." Comments are due July 22. A final assessment from Germany's Federal Joint Committee (G-BA) is expected in mid-September. ...