The FDA on Friday cleared a 2.4-mg injection of Novo Nordisk's semaglutide as an adjunct for chronic weight management in adults with a body mass index (BMI) of ≥30, or those with a BMI ≥27 plus at least one weight-related comorbidity. Novo Nordisk said the FDA nod makes the drug, which will be marketed under the trade name Wegovy, the first once-weekly GLP-1 receptor agonist approved for weight management in the US.
A 1-mg injectable dose of semaglutide was approved by the FDA in 2017 and is sold as Ozempic to treat type 2 diabetes. The latest filing was supported by results from the Phase IIIa STEP development programme, consisting of four 68-week trials, with about 4500 participants enrolled in all.
Results from STEP 1, the largest of the four, which included 1961 adults with an average BMI of 38 and comorbidities, showed that those who received Wegovy lost an average of 12.4% of their body weight compared to placebo. STEP 2 consisted of 1210 adults with an average BMI of 36 who also had type 2 diabetes, with results there showing those who got Wegovy lost 6.2% of their body weight compared to placebo. The drug was also evaluated in the STEP 3 and STEP 4 trials.
Novo Nordisk said Wegovy demonstrated a safe and well-tolerated profile across the STEP programme, with the most common adverse events being gastrointestinal (GI). Those usually subsided, but led about 5% of study participants to stop taking it. According to the FDA, the medication dose should be increased gradually over 16 to 20 weeks to 2.4 mg once-weekly so as to reduce GI side effects. A boxed warning is included on the drug's label about the potential risk of thyroid C-cell tumours, and the FDA doesn't recommend it be prescribed to patients with a personal or family history of medullary thyroid carcinoma or those with multiple endocrine neoplasia syndrome type 2.
Novo Nordisk plans to launch the drug later in June. The Danish drugmaker has not disclosed Wegovy's price yet, but spokesman Michael Bachner said it will be similar to its Saxenda (liraglutide) weight-loss drug, which is injected daily and now typically costs $1349 per month without insurance. Novo Nordisk is looking to see if there are trends among responders to Wegovy that could help doctors match the drug to specific patients, although it has not observed any yet, said Jason Brett, executive director of medical affairs for Novo Nordisk's US business.
Meanwhile, the company recently announced plans to start a Phase III trial in the second half of 2021 involving 1000 obese and overweight individuals to test an oral formulation of the drug versus placebo.
Last month, Eli Lilly indicated that it planned to seek regulatory approval for tirzepatide, a once-weekly dual GLP1/GIP agonist, after the drug showed A1c reductions as well as "significant weight loss" in type 2 diabetics participating in a Phase III study, one among several making up the SURPASS development programme. For more, see ViewPoints: Eli Lilly puts a tidy bow on tirzepatide package.
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