ACC: Waiting on the FDA's heart-helping verdict, J&J shares more positive CV data for Invokana

Johnson & Johnson's Invokana is waiting for a CV benefit indication from the FDA. (J&J)

ORLANDO, Fla.—Johnson & Johnson is waiting for word from the FDA on whether it’ll become the second diabetes drug in its class to snag an indication for cardiovascular risk reduction. But in the meantime, it’s trumpeting more outcomes data to support its case.

Sunday at the American College of Cardiology’s 67th Annual Scientific Session, the New Jersey drugmaker touted results showing that Invokana cut the risk of cardiovascular death or hospitalization for heart failure by 22% in high-risk Type 2 diabetes patients. That benefit was 39% greater among patients with a history of heart failure, according to J&J.

Across other subgroups of patients, Invokana’s effects on the risk of CV death or hospitalization for heart failure were “mostly comparable,” J&J said in a statement.

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.

“Hospitalization for heart failure and, even worse, cardiovascular death are on the minds of many doctors and patients who manage Type 2 diabetes,” Janssen R&D’s VP of medical affairs for cardiovascular and metabolism, Robert Cuddihy, M.D., said in a statement, adding that the data help “reinforce important additional clinical benefits” of Invokana.

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

The new results are part of an analysis of J&J’s Canvas trial, whose results the company unveiled last June at the American Diabetes Association's annual meeting. Those data showed that Invokana, like fellow SGLT2 product Jardiance from Boehringer Ingelheim and Eli Lilly, could slash the combined risk of heart attack, stroke and cardiovascular death among high-risk diabetes sufferers. But they also showed that, unlike Jardiance, Invokana doubled the risk of lower extremity amputations.

RELATED: J&J's Invokana continues downward market-share spiral as Lilly, BI's Jardiance advances

Since then, Invokana’s market share has taken a hit—and both the BI-Lilly team and AstraZeneca, maker of SGLT2 entrant Farxiga, have done their best to distance themselves, rolling out data to help prove the amputations uptick shown in Invokana patients isn’t a classwide effect.

But if J&J can snag a heart-helping indication from the FDA, it could get a leg up on its rivals. The company is seeking a green light for reducing the risk of major adverse cardiovascular events—a composite indication that covers heart attack, stroke and cardiovascular death. Jardiance’s label bears an indication specifically for reducing the risk of cardiovascular death, while AstraZeneca is still waiting for cardiovascular outcomes data that should arrive in the second half of this year.

Merck and Pfizer’s Steglatro won FDA approval late last year to become the fourth member of the SGLT2 class.