FDA Approves Pill Version Of Wegovy Weight Loss Drug

Novo Nordisk’s pill version of the Wegovy weight loss drug will be a test case for the fast-growing cash-paying consumer market.

The approval by the U.S. Food and Drug Administration this week is a boost for Novo, which has faced fierce competition from rival Eli Lilly. 

“A key part of making it a success will be attracting cash-paying consumers, a stark shift from a business model where drug pricing is managed through health insurance plans, which has dominated for decades,” according to Reuters. “Under a deal with the Trump administration in November, Novo and Lilly agreed to sell starter doses of their weight-loss pills, if approved, for $149 a month to U.S. Medicare and Medicaid patients and cash-paying customers who cannot get insurance coverage for the medications.”

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U.S. consumers should be able to obtain it in early January via multiple channels  including retail pharmacies such as CVS and Walmart, online platforms like GoodRx and telehealth partners including Ro and WeightWatchers.

“When Wegovy was first approved, it faced prolonged shortages,” notes NBC News. “To offset shortages this time, the company boosted production of the pill in preparation for its launch, a company spokesperson said.”

The share of U.S. Wegovy prescriptions --  until now injectable versions--  via self-pay channels has jumped from about 5% to double digits this year, according to the company. 

“The approval caps a turbulent year for Novo, which has been marked by multiple guidance cuts, mass layoffs, dramatic leadership shakeups, and a high-profile public bidding war against U.S. rival Pfizer,’ according to CNBC.  “Even as analysts and investors alike are mostly optimistic about the Wegovy pill U.S. launch, investors will be watching how Novo and its new pill will fare in relation to Lilly’s oral version. A first-mover advantage is no guarantee for future sector dominance and success.”

Novo Nordisk competitors have similar drugs in development. 

“Eli Lilly said recently that is has submitted orforglipron for FDA review. The drug won a priority review voucher from the agency, which could mean the agency will make a decision "within months,” according to NPR. “Meanwhile, another company, Metsera, has several obesity drugs in its pipeline, though none is in late-stage clinical trials yet. Novo Nordisk tried to acquire the company, but it ultimately lost out to Pfizer, which completed the acquisition that could ultimately be worth more than $10 billion."

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