Novo Nordisk’s weight-loss pill: Novo Nordisk won federal approval for a daily weight-loss pill, beating competitors to market with an oral alternative to injections that have reshaped obesity treatment.
The Food and Drug Administration authorised the 25-milligram semaglutide tablet, which will carry the Wegovy brand name already used for the company’s injected version. The same compound also appears in Ozempic, widely prescribed for diabetes.
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Novo’s American shares climbed 8 per cent in after-hours trading following the announcement. Rival Eli Lilly’s stock dipped 1 per cent.
Clinical trial results showed patients taking the pill daily for 64 weeks shed an average of 16.6 per cent of their body weight. Those given dummy pills lost 2.7 per cent.
The approval covers adults dealing with obesity or excess weight coupled with related medical problems, a description fitting millions of Americans. Government figures indicate 40 per cent of US adults meet obesity criteria, while recent polling suggests 12 per cent currently use GLP-1 medications.
Novo faces mounting pressure after a difficult stretch marked by falling share prices, profit downgrades and weakening Wegovy sales. Lilly has gained ground with Zepbound, its injectable medication now leading in weekly U.S. prescriptions.
The Danish pharmaceutical company hopes the pill’s head start will reverse that trend. Lilly expects approval for its own weight-loss pill, orforglipron, potentially by late March.
David Moore, who oversees Novo’s US operations, said the company has stockpiled the medication at its North Carolina manufacturing site to prevent shortages that plagued earlier launches. Industry watchers predict oral medications could claim roughly 20 per cent of what analysts forecast will become a $150 billion global market within a decade.
Pills address a practical barrier that keeps some patients from starting treatment: needle aversion. The medication does come with requirements. Users must take it each morning before eating, drinking or swallowing other pills, then wait 30 minutes. Lilly’s competing product won’t carry those timing restrictions.
Novo plans to ship the 1.5-milligram starter dose in early January. The company recently dropped Wegovy’s cash price to $349 monthly from $499, though standard list prices exceed $1,000.
Both Novo and Lilly agreed to provide introductory doses at $149 per month through Medicare, Medicaid and the White House’s TrumpRx direct-purchase program.
