Merck's Diabetes Franchise And The Perils In Proving A Drug's Medical Value
Merck’s Januvia (sitagliptin) and its metformin combination, Janumet, are important drugs for type 2 diabetes patients as well as for Merck’s bottom line. These drugs, which are DPP-4 inhibitors, account for more than $6 billion in sales for this drug giant. Given the growing incidence of obesity and type 2 diabetes in the world, this franchise is poised for continued growth.
However, Merck has competition in this field with a number of other drug companies, a notable one being Eli Lilly. Lilly has a variety of products for diabetics, including Jardiance (empagliflozin), a drug that acts by blocking SGLT2. (Lilly co-developed Jardiance with Boehringer Ingelheim.) Both Januvia and Jardiance lower high blood sugar, the cause of the downstream consequences of diabetes such as heart disease, kidney failure, blindness and amputations. However, just because a drug lowers blood sugar doesn’t ensure that it will reduce the ultimate complications of diabetes. Nevertheless, over the years diabetes drugs have been approved on the basis of blood sugar lowering alone.
However, last December, Lilly raised the bar for oral diabetes drugs with the acceptance by the FDA of its data showing that Jardiance not only lowered blood sugar but, in doing so, also reduced cardiovascular events in diabetic patients with heart disease. These data were generated in a trial known as the EMPA-REG OUTCOME trial. Last December, the FDA effectively blessed this work and allowed Lilly to add the cardiovascular outcome benefit to the Jardiance label. This was a big advantage to Lilly because its sales r Continue reading