Novo Nordisk’s oral semaglutide is heading toward a market shake-up. And the company wants to see that happen sooner rather than later.
The Danish drugmaker is considering using a priority review voucher for the candidate, a company spokesman confirmed by email. Doing so would expedite semaglutide’s trip down the regulatory pathway—and hasten a head-to-head battle in the diabetes sphere with drugs including Eli Lilly’s Trulicity.
Industry watchers have been eagerly awaiting Novo’s prospect, which would be the first oral option in its class of GLP-1 drugs. A different formulation of the therapy is already approved as a long-acting injectable dubbed Ozempic that grabbed an FDA approval late last year.
In addition to boasting a convenience factor against injectable GLP-1s, semaglutide has also already racked up a raft of positive data to support a green light. And while the drug didn’t hit the statistical significance mark in a recent cardiovascular outcomes study, the result didn’t let down some analysts—including those at Credit Suisse, who were “never expecting” a significant reduction in major cardiovascular events given the trial’s small size, CS’s Vamil Divan, M.D., wrote in a Friday note to clients.
RELATED: Novo data buttress its oral semaglutide case, this time in kidney-impaired patients
For diabetes drugs, nabbing a heart-helping indication “is always an upside scenario,” Divan added.
He expects to see Novo use the voucher, which could secure it an approval before the end of next year. Meanwhile, payer discussions will start up in advance of the go-ahead “so that coverage in 2020 will look strong,” Divan wrote.
RELATED: Novo has a big pricing decision to make with semaglutide. Which way will it go?
“All we need now is the price, where we would encourage Novo to go low,” he noted.
Lilly, for its part, is working to shore up its GLP-1 share with a next-generation product of its own. The up-and-comer, a dual GIP and GLP-1 receptor agonist, posted study data in October showing it could significantly reduce blood sugar and increase weight loss.
“This drug is setting up to be perhaps the most critical part of LLY's diabetes strategy going fwd … especially in the face of Novo's new launches,” Evercore ISI analyst Umer Raffat wrote at the time.