Johnson & Johnson bags long-awaited cardiovascular nod for diabetes drug Invokana

Invokana
The FDA green-lighted Johnson & Johnson's Invokana for CV risk reduction Tuesday. (Johnson & Johnson)

It’s been more than a year since Johnson & Johnson trotted out results showing Invokana could improve heart safety for patients with Type 2 diabetes. And as of Tuesday, the company’s reps can finally tout those benefits.

The FDA approved the drug, a member of the SGLT2 class, to reduce the risk of major heart problems—including heart attack, stroke and cardiovascular death—in high-risk Type 2 patients. And as the New Jersey drugmaker was quick to point out, Invokana is now the only diabetes therapy to boast that particular indication.

RELATED: Lilly nets best-case Jardiance nod from FDA, clearing reps to talk up CV risk reduction

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

That’s not to say its rivals don’t have similar nods, and it’ll be up to J&J and its reps to make the distinction for doctors. Eli Lilly and Boehringer Ingelheim’s Jardiance—which became the first diabetes drug to show it could improve CV outcomes back in 2015—has boasted of a CV death risk reduction on its label since late 2016, meaning that it’s been the only drug in its class with a heart safety indication for nearly two years.

J&J will now be working to catch up, and it’ll do so armed with phase 3 data that showed it could cut the combined risk of heart attack, stroke and CV death by 14%. That number matched the composite percentage Jardiance put up in its own outcomes trial; while Jardiance didn’t make much of a dent in the risk of heart attack or stroke, Invokana showed it could cut down risks in those measures by 15% and 10%, respectively.  

RELATED: Johnson and Johnson's Invokana matches Jardiance's 14% reduction in major CV events—but doubles amputation risk, too

Invokana, though, also comes with a safety issue that its rival doesn’t, and that’s a risk of lower extremity amputations. It now bears a black box warning, the FDA’s most serious, highlighting the risk of toe, midfoot and leg amputations. That warning may have had something to do with a market-share decline that J&J cited as the reason behind its year-over-year sales drop in the second quarter.

Still, the pharma giant is hopeful its new approval can help boost sales, which amounted to $190 million in the most recent quarter, representing another decline. It’ll also be looking to build its share back up before another SGLT2 competitor—Farxiga from AstraZeneca—can snag a similar cardiovascular approval.