The FDA has spoken: Novo Nordisk’s diabetes fighter Victoza officially reduces the risk of heart attack, stroke and cardiovascular death, a trifecta approval that gives the Danish drugmaker a better shot at defending its pole position in the GLP-1 class.
The cardiovascular risk-reduction nod itself wasn’t a surprise; an FDA expert panel overwhelmingly backed a label change in June. But the fact that Novo can now tout Victoza as a preventive in all three of those categories is significant, not only in conversations with doctors, but perhaps more importantly, with payers that are putting unprecedented pressure on diabetes meds.
“Now comes the interesting part,” Novo CMO Todd Hobbs said in an interview Monday, as payers digest the new approval.
The approval comes at a time when diabetes experts have stepped up their attention to the cardiovascular risks that come with the disease. Drugs such as Victoza and its follow-up weekly med semaglutide, plus Eli Lilly and Boehringer Ingelheim’s Jardiance, have delivered data that prove they can not only lower blood sugar but stave off CV problems, and that’s changing the game in diabetes treatment, Hobbs said.
“Mindsets are changing,” he said. “The expectations are that agents not only don’t increase the risk of cardiovascular problems”—a worry that caused the FDA to raise its bar for diabetes drug approvals—“but now the expectation that therapies will benefit CV endpoints.
“I honestly think that prescribers and payers think we have a lot of good diabetes therapies, so the bar [for new ones] is pretty high.”
Now that Victoza has joined Jardiance as an approved CV risk prevention tool, payers will be crunching the data on their own patients. They will be looking at “how to measure the cost savings of preventing cardiovascular disease,” Hobbs pointed out. “They will take this data and apply it to their systems” to assess the results for their own patient populations and the costs of treating those at high risk of CV complications, which is the patient group covered by the LEADER trial.
“We can have those kind of value discussions,” Hobbs noted, though the real push won’t begin until the middle of next year, when 2019 formulary positioning comes up for grabs.
When Lilly and Boehringer went to the FDA for their Jardiance label update, the agency added only the cardiovascular death benefit, though the EMPA-REG outcomes trial showed Jardiance cutting heart attack risks, too. The death benefit is what drove the overall success in that trial.
Comparing the two trials is “apples and oranges” to an extent, Hobbs pointed out, because the two drugs work differently. Jardiance, of course, belongs to the SGLT2 class, which works by flushing excess glucose through the kidneys, while Victoza and other GLP-1s are incretin mimetics. But Jardiance didn’t deliver a stroke-prevention benefit, and Victoza did, Hobbs noted, and that made a difference at the FDA.
“We were confident in the data that it was strong, but with the FDA never take anything for granted,” Hobbs said. “When you look at the three components that make up the primary endpoint, all three went in the right direction favoring liraglutide. FDA felt strongly it could give a full approval” on the composite CV risk measure that comprises all three, commonly known as MACE.