Merck, Pfizer make their PhIII case for an SGLT2 latecomer to the blockbuster showdown in diabetes
What do you do when you’re the last to arrive at the SGLT2 party, long after it got started? You start lining up data that start to differentiate your Type 2 diabetes drug, at least somewhat.
That’s what Merck and Pfizer were aiming for over the weekend when their investigators offered up solid data from two new Phase III trials of ertugliflozin.
Pegged by analysts for a likely FDA approval by the end of this year (there’s a December PDUFA date on three NDAs for the drug and these two combos), the researchers touted results that demonstrated the drug’s ability to effectively cut A1C when combined with either Merck’s DPP-4 drug Januvia or the mainstay metformin.
The magic number in diabetes research is a blood sugar number of 7%. Any A1C level under that marks disease control, while physicians view anything above it as trouble.
The ertugliflozin/Januvia combo did best, slashing A1C by 1.6% and 1.7% for both, compared with a 0.4% drop in the control group. Also, significantly more patients got under the 7% mark with the combo than the placebo group. The two drugs scored below-7 numbers among 35.7% and 31.3% of patients, respectively, compared with 8.3% for the placebo arm.
Combining ertugliflozin with metformin against metformin alone among patients whose disease was not controlled by the old generic, there was a drop in AIC of 0.7% and 0.9% for the combo against zilch response for metformin alone.
Looking past the prospective OK — when Merck and Pfizer will start to go toe-to-toe with Jardiance from Eli Lilly and Boehringer, Invokana from J&J and AstraZeneca’s Farxiga — the two major league partners are executing on a late-stage cardio outcomes trial, looking to match or beat Eli Lilly’s drug. That data, though, won’t come until 2019 after researchers opted to double the late-stage cardio study to 8,000 patients.
The Invokana cardio data, though, arrives on Monday.