Novo Nordisk announced that the highly popular drug could have expanded FDA approval in six months.
Novo Nordisk recently announced that its headline-making weight loss drug Wegovy could receive expanded US Food and Drug Administration (FDA) approval within six months, opening the door to much more readily available coverage by health insurance plans.
The drug is already highly sought-after, but is not necessarily covered by most policies.
Novo Nordisk’s chief financial officer Karsten Munk Knudsen said that the company’s application for approval of Wegovy as a cardiovascular disease reduction medication has received priority review status. If the FDA does provide the drug this approval, it will open the door to improved availability of coverage through health insurance.
“I would say from today, [the outcome will be] less than six months,” said Knudsen in a recent interview on CNBC.
The priority status arrived quickly after the application was submitted, as Novo Nordisk had not shared any timeline in its third quarter earnings announcement in which it stated that it was seeking the expanded FDA approval. That said, the pharmaceutical company was already recording record profits and sales for the third quarter, greatly due to the success of the Wegovy prescription obesity drug.
Health insurance coverage typically becomes more available when the FDA enhances approvals.
In August, the company released late-stage trial data which showed that Wegovy reduced the risk of major cardiovascular events such as stroke and heart attack by 20 percent when compared to the placebo group’s results.
“The SELECT study is, in an obese population with established cardiovascular disease, does Wegovy reduce cardiovascular risk? And the answer is, yes it does, by 20%,” said Knudsen in the recent interview.
The results of that trial were a major step forward for Novo Nordisk, as Wegovy had been sliding into the perception of being a “vanity drug” but is now showing strong promise that it also offers health benefits to its users. The importance of this change in perception was reflected in the company’s stock, which rose immediately. That said, it has also given hope to patients who want to use this medication to help control their obesity, but who require health insurance coverage to make it affordable.