Novo Nordisk launches higher-dose Wegovy

- Novo Nordisk launched higher-dose Wegovy in the United States on April 7 after FDA approval in March, adding a 7.2 mg semaglutide option. - In Novo Nordisk’s STEP UP trial, Wegovy HD delivered 20.7% mean weight loss at 72 weeks, with about one-third of patients reaching 25%. - Novo Nordisk presented additional STEP UP and OASIS 4 analyses at ECO 2026 in Istanbul from May 12 to May 15.

Novo Nordisk has started selling a higher-dose version of Wegovy in the United States, extending its semaglutide obesity portfolio after the U.S. Food and Drug Administration approved the product in March. Wegovy HD is a 7.2 mg once-weekly injection, compared with the already marketed 2.4 mg dose, and Novo Nordisk said it is intended to give physicians and patients another treatment option. The launch follows a March 19 FDA approval and an April U.S. rollout timeline flagged by the company. Additional data released this month at the European Congress on Obesity in Istanbul added new detail on how the higher dose performed in trial subgroups. ### When did the higher-dose version actually arrive? Novo Nordisk said on April 7 that Wegovy HD had launched in the United States, weeks after winning FDA clearance for adults with obesity or overweight with at least one weight-related condition. Reuters, cited by Economic Times Pharma, reported the product became available through the company’s U.S. channels as Novo tried to broaden its obesity offering. (prnewswire.com) The FDA said the decision was granted under the Commissioner’s National Priority Voucher pilot program. March 19 was the formal approval date. Novo Nordisk said then that Wegovy HD complements the existing 2.4 mg Wegovy injection, which is already approved in the United States for chronic weight management and cardiovascular risk reduction. The company said it expected the higher dose to launch in April 2026. (pharma.economictimes.indiatimes.com) ### What did the main trial show for Wegovy HD? Novo Nordisk said the STEP UP phase 3 trial tested semaglutide 7.2 mg against semaglutide 2.4 mg and placebo over 72 weeks in more than 1,400 adults with obesity without type 2 diabetes. According to the company, patients on the 7.2 mg dose lost 20.7% of body weight on average, compared with 17.5% on 2.4 mg and 2.4% on placebo. Around one-third of participants on Wegovy HD achieved weight loss of 25% or more, Novo said. (biospace.com) The FDA said the approved indication covers weight loss and long-term maintenance of weight loss for certain adult patients. Novo Nordisk described the safety and tolerability profile in STEP UP as consistent with the 2.4 mg dose. ### What new analyses did Novo Nordisk present in May? (prnewswire.com) On May 12, Novo Nordisk presented a STEP UP sub-analysis at the European Congress on Obesity showing that patients classified as early responders to semaglutide 7.2 mg achieved 27.7% mean weight loss at week 72. The company defined early responders as patients who had lost at least 15% of body weight by week 24. About 27% of participants on the 7.2 mg dose met that threshold, compared with about 21% on 2.4 mg and 3% on placebo. (fda.gov) The same Novo Nordisk release said 84% of weight loss with semaglutide 2.4 mg and 7.2 mg could be attributed to reductions in fat mass, while muscle function and muscle health were preserved. A separate market summary on May 20 said Novo Nordisk also presented OASIS 4 and STEP UP sub-analyses showing improved physical function and favorable body-composition effects across oral and injectable Wegovy patient groups. (biospace.com) ### How does this fit into Novo Nordisk’s broader Wegovy push? Novo Nordisk’s recent materials show the company is expanding Wegovy across multiple formulations. Its Q1 2026 investor presentation said U.S. brand expansion continued with FDA approval of Wegovy HD, while the company’s newsroom listed new May data on Wegovy pill and subgroup analyses in women and other populations. (biospace.com) The next public marker is additional semaglutide data. Novo Nordisk said on May 19 it would unveil new findings on semaglutide and liver disease, while ECO 2026 materials remain available through the company’s science hub and newsroom. (novonordisk.com 1) (novonordisk.com 2)

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