Merck and Pfizer have landed an FDA approval to start marketing ertugliflozin, marking a late arrival for a therapy that will now go toe-to-toe with some deeply entrenched rivals in the SGLT2 niche.
The FDA noted the approval on its site, hitting the green light for the single therapy as well as combinations with Merck’s Januvia or metformin, the standard therapy for diabetes. Curiously, though, the companies have yet to put out a release marking the occasion.
While the companies’ execs have sounded confident that they can get into the marketing mix with an appealing product for the mass market, the pharma giants will have to maneuver around three key players.
Eli Lilly scored its OK for its SGLT2 inhibitor Jardiance more than three years ago, giving it time to follow up with impressive cardio data. J&J has also had time to establish a cardio profile for Invokana while AstraZeneca will post its cardio results in 2019.
Just because they’re last, though, doesn’t mean that they have to be stuck in that position. The research teams for both companies decided back in mid-2016 to double down on their own major market cardio study, recruiting 8,000 patients — double the original mark — in a major trial aimed at disrupting the market.
Sanofi and Lexicon, meanwhile, plan to pitch their SGLT1/SGLT2 drug sotagliflozin next year after racking up positive late-stage data of their own for yet another related therapy that will be making its own claims related to range of targets and impact.
Merck and Pfizer can now start touting a clean set of safety and efficacy results, looking to gain some initial traction and see if they can start living up to the blockbuster expectations they’ve managed to spark. Diabetes is a huge market, with a large swath of undiagnosed or poorly treated patients. And that gives long distance runners like Merck and Pfizer hope that there’s plenty of major market opportunity left to explore.
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