Novo Nordisk (NVO) is planning to submit regulatory filings to obtain FDA approval for a high-dose version of its blockbuster weight loss therapy Wegovy in the U.S., Bloomberg News reported on Tuesday, citing the company’s chief scientific officer, Martin Lange.
Earlier this year, the Danish drugmaker said that patients who received Wegovy at a higher dose of 7.2 mg experienced ~21% weight loss over 72 weeks in a Phase 3 trial, compared to ~18% and ~2% weight reduction seen in those who received regular Wegovy and placebo, respectively.
In July, Novo (NVO) sought EU approval for the high-dose injectable, submitting a marketing application to the European Medicines Agency based on late-stage trials in which 1 in 3 participants who received 7.2 mg of Wegovy witnessed 25% or more weight loss.
Despite its intense rivalry with Eli Lilly (LLY) in the obesity drug market, the company had yet to formally announce its plans for the high-dose version in the U.S. However, at the European Association for the Study of Diabetes conference in Vienna, Lange disclosed NVO’s intentions to seek FDA approval for the drug. “Obviously, our competitors have optimized the dosing,” he said during an interview, adding, “Now with high-dose Wegovy, we’ve done the same.”