Once upon a time, Merck was looking to candidate omarigliptin—a once-weekly DPP-4 diabetes med—to build up declining sales of its Januvia/Janumet franchise.
But no more. Late last week, the pharma giant quietly announced that it had dropped the Phase III prospect it once regarded as a key cog in its diabetes plans.
So why the change of heart? A new report from healthcare analytics firm Advera Health Analytics found that the weekly therapy came along with more serious side effects than Januvia in two studies. Omarigliptin turned up higher rates of prostate cancer and cardiovascular and hepatobiliary issues, or problems with the liver, pancreas or digestive system, it found. And that kind of profile could have made the drug a hard sell.
Merck says the decision didn’t result from any safety or efficacy concerns. Instead, it may have taken a look at the diabetes landscape and seen a difficult future for the DPP-4 contender.
Such a conclusion would come as no surprise, considering recent developments in the diabetes world. Last year, SGLT2 med Jardiance from Eli Lilly and Boehringer Ingelheim made headlines when it became the first diabetes med to cut down on the combined risk of heart attack, stroke and cardiovascular-related death. Last month, GLP-1 product Victoza from Novo Nordisk accomplished the same feat. And those outcomes leave DPP-4s—which have shown that they don’t increase the risk of serious cardiovascular events, but don’t reduce it, either—out in the cold.
And omarigliptin’s once-weekly advantage may not have done enough to change that, considering the long-acting GLP-1 options out there. Eli Lilly is already marketing once-weekly Trulicity, and Novo is in Phase III with its own long-lasting GLP-1, semaglutide.
But that’s not to say Merck will be left in the dust. With omarigliptin off its hands, the company plans to double down on its pipeline efforts, which include ertugliflozin--an SGLT2 prospect of its own.
- read Merck's release
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