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Wegovy's Maker Is Betting Big That the Drug Can Treat More Than Just Obesity - Here's Their Plan

Novo Nordisk has announced that the FDA may extend the clearance of their weight reduction drug Wegovy by as little as six months.

Following an interview with CNBC, Chief Financial Officer Karsten Munk Knudsen stated that the Danish pharmaceutical company had received priority review for its application seeking approval of Wegovy as a therapeutic intervention to lower the risk of cardiovascular disease.

If health officials provide their stamp of approval, the insurance market may be more willing to cover the drug.

Knudsen's statement to CNBC's Julianna Tatelbaum on "Street Signs" strongly suggests that the FDA will decide within six months.

Novo Nordisk announced its decision to seek expanded FDA approval in its third-quarter earnings report released Thursday. There was, however, no concrete date given. Additionally, the firm reached record levels of profitability and income throughout the stated time range, mainly owing to the overwhelming success of its anti-obesity drug.

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Wegovy reduced the occurrence of major cardiovascular events like heart attacks and strokes by 20% compared to a placebo, according to results from late-stage testing completed in August.

The SELECT research aimed to determine whether or not Wegovy usage reduced cardiovascular risk in a group with preexisting cardiovascular disease. Knudsen confirmed the existence of a 20% increase in his statement released on Thursday.

The results of the carefully observed "SELECT" trial were seen by many as helpful for Novo Nordisk's efforts to change the public's view of Wegovy beyond that of a drug used mainly for cosmetic purposes.

The firm's stock, which has been performing well this year, received a boost from the announcement. On Thursday morning, there was a 1.5% increase in share price following the release of the company's results report. The share price has risen by almost 45% since the beginning of the year.

Knudsen claims the company will provide a full report on the trial's findings in roughly a week. The FDA will then have six months to make a final determination.

He said that insurance companies are more likely to pay for the treatment now that its potential uses are expanding, thanks to the approval. 

The medication costs $1,350 a month in the United States, and some insurance companies have shown reluctance to cover it because it is being used only for weight reduction.

Knudsen argues that the monetary value of goods reflects their use in society.

In conversations with payers and insurers, developing more data relevant to multiple health problems, including cardiovascular disease, chronic renal disease, and other comorbidities, significantly contributes to the overall value story.

However, even with approval, supply restrictions may slow down the medicine's rollout. Knudsen claims that the company is now working to raise output rates.

The presenter promised a dramatic expansion of Wegovy's availability in the future.

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