SGLT2 drugs recently looked as though they might get a classwide boost when partners Eli Lilly ($LLY) and Boehringer Ingelheim announced a cardiac benefit for their entrant, Jardiance. But just a few weeks later, the FDA has handed Johnson & Johnson ($JNJ) a safety setback that could give its SGLT2 rivals an advantage.
U.S. regulators have strengthened the warning on the New Jersey pharma giant's Invokana and its metformin combo med Invokamet, adding information about bone mineral density and an increased risk of bone fractures, they said late last week. They've also revised the "Adverse Reactions" section on both drugs' labels.
It's a setback for Invokana, which has been posting some serious growth as of late. Last quarter, sales of the pair more than doubled to $318 million despite newer competition from Jardiance, the BI/Lilly therapy, and AstraZeneca's ($AZN) Farxiga. And it's a warning that those competitors aren't facing.
On the other hand, Jardiance's recent cardiac win could still help out Invokana against other diabetes classes, some analysts have predicted. Late last month, Lilly and Boehringer announced Jardiance had shown it could lower the risk of heart attack, stroke and death from cardiovascular causes. While DPP-4 meds, like Merck's ($MRK) giant Januvia, recently proved they don't pose cardiac risks, Jardiance is the first to display a benefit in cutting down those dangerous conditions.
DPP-4s come with their own concerns, too. A couple of weeks back, the FDA issued a warning that the class could cause "severe and disabling" joint pain and added the warning to the official labels of all of its members.
So will the various safety worries and benefits vault one class of diabetes meds high enough to squeeze out another? Not likely, according to some industry-watchers. As Peter Stein, Merck's VP of clinical research in diabetes and endocrinology, told FiercePharma earlier this month, "we individualize therapy" in diabetes.
"It's not a one-size-fits-all situation. I'm going to reach for certain drugs for certain patients."
Bernstein's Tim Anderson recently pointed out in a note to clients that prescribers could start embracing DPP-4/SGLT2 combos, too. That would help Januvia, for one, stay in "reasonable shape" in the face of potentially better-for-the-heart competition from Jardiance.
- read the FDA announcement
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