Diabetes, Results

Merck, Pfizer tout PhIII diabetes data as ertuglifozin heads to the FDA

Merck and Pfizer rolled out positive Phase III data for their SGLT2 diabetes drug ertugliflozin at the annual EASD meeting in Germany today.

The data, with two doses of their drug added to Januvia and metformin slicing A1c levels by an extra 0.69 percent and 0.76 percent, will be added to their regulatory filings for this drug, now slated to land at the FDA before the end of this year with Europe and other markets to follow in 2017.

The magic number for A1C is 7.0%, which tells patients that the disease is being well managed and under control. And in the two drug arms for the pharma giants, 32.1% and 39.9% of patients cleared that bar—compared to a less than stellar 17% of the placebo arm. Investigators also tracked a relevant 4.4 and 3.7 pound placebo-adjusted weight loss for their drugs. And there were significantly improved levels of fasting plasma glucose.

Merck’s hoping for some big returns on a combo for Januvia. Eli Lilly has generated lots of buzz with its SGLT2 drug Jardiance after demonstrating cardio benefits for patients. And Pfizer/Merck have some big plans on that score with a big cardio outcomes study in the works for ertugliflozin.

It’s a competitive field, with J&J rolling out its combo Invokamet and AstraZeneca out with Farxiga. The market is huge, though, with some 400 million patients globally and more being diagnosed at a rapid pace.

“Type 2 diabetes is a progressive disease and these study results help support the clinical profile of ertugliflozin as an add-on therapy for patients who may require multiple treatment combinations to help reach their blood sugar goals,” said James Rusnak, M.D., Ph.D., chief development officer, cardiovascular & metabolics, Pfizer.

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RAPS Regulatory Convergence 2017