Company: Merck & Co.
2016 U.S. sales: $2.29 billion
Drug class: DPP-4
Merck’s Januvia has faced its share of obstacles, but it remains a mainstay of diabetes treatment—and of Merck’s revenue mix. The drug brought in $3.91 billion worldwide, $2.29 billion of that in the U.S., and that doesn’t include its combo-med cousin, Janumet, which makes an appearance lower down on this list.
Januvia sales suffered several years ago after safety questions hit the entire class of dipeptidyl peptidase-4 (DPP-4) inhibitors as well as the rival GLP-1 class; U.S. and European regulators later joined forces to sweep worries about pancreatitis and pancreatic cancer aside. Januvia since rebounded, and last year, its safety profile got a boost when a cardiovascular safety study turned up no additional risks. Importantly, that study didn’t turn up an increase in the risk of heart failure, as some had feared after some red flags for AstraZeneca’s DPP-4 med, Onglyza.
But that same study—called TECOS—didn’t show that Januvia conferred any CV benefits, either, and a couple of its competitors have: Eli Lilly and Boehringer Ingelheim’s SGLT2 drug Jardiance and Novo Nordisk’s GLP-1 med Victoza. Jardiance’s ability to cut CV risks won an FDA approval, and Novo is awaiting a decision on its own CV-risk update to Victoza’s label. What’s worse, the FDA refused to add the TECOS safety data to Januvia’s labeling.
Merck has its own SGLT2 drug in the pipeline, partnered with Pfizer, and it’s also working on an SGLT2-Januvia combo. In the meantime, Januvia remains an important tool in doctors’ box of diabetes remedies, Merck executives say, pointing out that diabetes patients often need to try different drugs, or combinations of drugs, as their disease progresses.
As payers press for discounts in the DPP-4 field as well as in other diabetes classes, Merck has experimented with pay-for-performance contracts linking Januvia costs to its performance. Last year, the drug giant inked a deal with Aetna to peg Januvia rebates to its effectiveness in managing type 2 diabetes.