Novo Nordisk Secures Approval for Higher-Dose Wegovy, Sues Hims Over Compounded Version
European regulators approved a 7.2mg "megadose" of Novo Nordisk's Wegovy involving three weekly injections. The Danish drugmaker filed suit against Hims & Hers after the telehealth company briefly launched a compounded oral semaglutide product.
Regulators are now allowing for a 7.2mg dose of weight loss jab Wegovy, involving three injections taken in one sitting, once a week. Athlone based Novo Nordisk is confirming its European Medicines Agency application has been approved. The pharma group is set to expand its Midlands facility so it can produce a pill version of the popular weight loss drug.
Novo Nordisk slammed the telehealth giant with a lawsuit over its short-lived attempt to knock off the Danish company's new weight-loss pill. On Feb. 5, the telehealth company launched a compounded version of Novo's Wegovy pill for just $49 for the first month and $99 each month after. Hims' version would have launched a month after Novo's and for significantly less than the $149 monthly price from Novo Nordisk.
Pressure quickly mounted for Hims & Hers Health. FDA Commissioner Marty Makary said the agency would target "mass-marketing" of "illegal copycat drugs." A day later, the agency said it would restrict active pharmaceutical ingredients intended for compounded GLP-1 drugs. GLP-1 drugs include weight-loss and type 2 diabetes treatments. The same day, Mike Stuart, general counsel for Health and Human Services, asked the Department of Justice to investigate whether Hims violated the Federal Food, Drug and Cosmetic Act.
Hims & Hers pulled its compounded oral semaglutide from the market on Feb. 7. The company cited "constructive conversations with stakeholders across the industry." Novo's lawsuit followed on Feb. 9. The drugmaker says Hims is "deceiving patients and putting their health at risk." Hims batted back, saying the suit is a "blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care."
At one point, the supply of branded GLP-1 drugs was running short. Under federal regulations, compounders can step in to help offset the supply shortage. But the FDA determined Novo had resolved semaglutide's shortage in February 2025. Still, Hims and other compounders have said they fill an important need, making personalized dosages not available from the branded company.
The move comes as Eli Lilly nears potential Food and Drug Administration approval of its new obesity-treating pill, orforglipron, and amid looming competition from big-name companies like Amgen, Pfizer, Roche and Viking Therapeutics. Hims & Hers Health has yet to report its 2025 sales, but analysts polled by FactSet expect the company to put up $2.35 billion for the year. That would represent 59% year-over-year growth. All but 2% of that is expected to come from online sales. The balance is wholesale revenue. Analysts expect the company to report $52 million in free cash flow for 2025.