With diabetes rivals coming up with heart-helping outcomes data, Merck at least wants data on its label showing its Januvia doesn’t hurt heart health. U.S. regulators, though, say not so fast.
Friday, they hit the New Jersey drugmaker with a complete response letter rejecting Merck’s sNDAs for Januvia and related combos Janumet and Janumet XR. The company had sought to add results from its TECOS outcomes trial—a heart study that turned up no red flags—to all three drugs.
“Merck is reviewing the letter and will discuss next steps with the FDA,” it said in a statement.
The label update would have given the med a boost against in-class DPP-4 rivals Onglyza from AstraZeneca and Nesina from Takeda, both of which have posted trial results suggesting an increased risk of heart failure hospitalizations.
It also would have bolstered Januvia against out-of-class meds that have a cardiovascular leg up. In 2015, Eli Lilly and Boehringer Ingelheim’s SGLT2 med Jardiance became the first diabetes therapy to show it could cut the combined rate of heart attack, stroke and death from cardiovascular causes. The next year, Novo Nordisk’s GLP-1 product Victoza followed suit.
To some analysts, those results spelled doom for DPP-4s, but Merck saw things differently. “Patients with diabetes need more than one agent, and often more than two agents, to get to goal,” Peter Stein, Merck’s then-VP of clinical research in diabetes and endocrinology, said in a 2015 interview.
Still, the pharma giant is pursuing approvals for its own SGLT2 med that it hopes can replicate Jardiance’s CV benefits. Last month, Merck and partner Pfizer announced that the FDA and EMA had accepted applications for candidate ertugliflozin and for two combos containing the prospect, too.
If approved, it’ll have to battle more than just Lilly and BI’s entrant, though. The class already features Johnson & Johnson’s Invokana, whose own outcomes data is due later this year, and AstraZeneca’s Farxiga.