Johnson & Johnson has been waiting for its chance to tout Invokana’s cardiovascular benefits for diabetes patients, but thanks to an FDA delay, that won't be happening anytime soon. In the meantime, though, the diabetes drug still has good news to celebrate.
On Monday, the New Jersey drugmaker's Janssen unit said it cut a renal outcomes study short after a positive performance from the diabetes drug—news that came just a few days after the FDA said it would push back its verdict on a new indication for reducing the risk of major CV events in patients with Type 2 diabetes. After requesting and receiving additional analyses from J&J, the agency now expects to hand down a decision in October.
The delay sets Invokana further behind Eli Lilly and Boehringer Ingelheim's Jardiance, which in December got clearance to tout a 38% reduction in cardiovascular death on its label. And it whittles down the drug's potential lead on Farxiga; its maker, AstraZeneca, will have cardiovascular outcomes data in hand next year. The three drugs are duking it out in the marketplace, but Invokana’s label bears an amputation risk warning that its rivals don’t.
In diabetes patients with chronic kidney disease, though, J&J has the chance to beat its in-class rivals to the punch. Invokana has already nailed the criteria to show that it delivers kidney-related benefits when paired with standard-of-care therapy. The drug showed it can cut the combined risk of disease advancing to dialysis or kidney transplantation, waste product creatinine doubling in the blood, and renal or cardiovascular death.
And now, Invokana “has the potential to be the first new therapy in more than 15 years for slowing the progression of chronic kidney disease in patients with Type 2 diabetes,” the company said in a statement.
The opportunity is a big one: 160 million Type 2 diabetes patients are at risk for developing CKD, which can increase the risk of kidney failure and cardiovascular disease, J&J said.
But Farxiga and Jardiance will be looking for their own pieces of the pie down the line. AstraZeneca started up its renal outcomes study in late 2016, and the Lilly-BI team embarked on its own kidney study last June.