Through the FDA’s priority voucher program, Novo Nordisk said Nov. 26 it has filed an application seeking approval of its Wegovy 7.2 milligram injection.
Wegovy (semaglutide) is currently approved in 0.25, 0.5, 1.7 and 2.4 milligram doses. The injectable GLP-1 drug is indicated for obesity, overweight with at least one weight-related comorbid condition, weight-related cardiovascular disease, and metabolic dysfunction-associated steatohepatitis.
The investigational 7.2 milligram injection could offer greater weight loss results, Novo Nordisk said in a news release, as the dose led to an average 20.7% loss in body weight in a 72-week clinical trial. The phase 3 trial compared weekly Wegovy doses of 2.4 milligrams and 7.2 milligrams in 1,407 adults with obesity.
The 2.4 milligram cohort lost an average 17.5% in body weight, and the placebo group saw a 2.4% reduction.
Novo Nordisk said it expects the FDA’s review within one to two months after the agency accepts the filing. The average timeline is 10 to 12 months. The expedited review is through the Commissioner’s National Priority Voucher program, which is eligible to drugmakers “aligned with U.S. national priorities,” according to the FDA.
