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.
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.
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.
A Product Manager with expertise in pharma marketing and sales operations