No company playing from behind in a competitive market wants to land a serious new safety warning. But that’s exactly the position Johnson & Johnson is in with Type 2 diabetes med Invokana.
On Tuesday, the FDA concluded that the SGLT2 drug—along with related combos Invokamet and Invokamet XR—caused an increased risk of leg and foot amputations, and it mandated that J&J update its labels accordingly. Regulators are requiring the New Jersey drugmaker to add a black-box warning, the agency’s most serious, to describe the risk, they said.
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The FDA’s decision follows a MedWatch safety alert from this time last year, which regulators issued after finding that patients in the Invokana arms of J&J’s two cardiovascular outcomes studies for the med were about twice as likely to experience amputations than were those in the placebo groups.
Some Invokana patients suffered more than one amputation, with a portion of those patients needing amputations on both limbs.
Now, regulators say doctors should “consider factors that may predispose patients to the need for amputations”—such as a history of prior amputation, peripheral vascular disease, neuropathy and diabetic foot ulcers—before prescribing Invokana.
J&J's Janssen unit, for its part, said in a statement that "patient safety is our highest priority" and that it was "working with FDA to include this information in the prescribing information" for Invokana.
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J&J had been hoping the trials, dubbed Canvas and Canvas-R, would turn up results that would make physicians more inclined to prescribe the product, not less. After all, SGLT2 rival Jardiance from Eli Lilly and Boehringer Ingelheim has already showed it can cut the combined rate of heart attack, stroke and cardiovascular death in high-risk Type 2 patients, and J&J is crossing its fingers that its med can do the same in an upcoming trial.
Now, though, “the increasingly differentiated labels and data to date suggest that … Jardiance likely will be a near-term beneficiary of further and perhaps accelerated market share losses for Invokana,” Leerink Partners analyst Seamus Fernandez wrote in a note to clients.
He predicted the “immediate reaction” from doctors would be to switch patients away to either Jardiance or AstraZeneca’s SGLT2 entrant, Farxiga, just as they years ago switched patients from GlaxoSmithKline’s Avandia to Takeda’s Actos in the wake of concerns about a potential Avandia cardiovascular risk.
J&J investors don’t need to panic, though, he wrote. “We believe a dramatic impact on the class is unlikely,” he said, noting that the company’s situation “could be further mitigated by a directionally positive result” from the outcomes studies on CV risk reduction.