US FDA approves higher dose of Novo's Wegovy under new fast-track review program

March 19 (Reuters) - Novo Nordisk NOVOb.CO said on Thursday the U.S. Food and Drug Administration has approved a higher dose of its blockbuster weight-loss drug Wegovy.

The 7.2-milligram dose of Wegovy was approved under the FDA Commissioner's National Priority Voucher program. The vouchers, launched in June, can be used to secure FDA decisions on selected drugs in one to two months, compared with the typical timeline of about 10-12 months.

The Danish drugmaker has struggled to maintain momentum in the lucrative obesity treatment market amid fierce competition from U.S. rival Eli Lilly LLY.N and "unprecedented" price pressures driven by President Donald Trump's efforts to cut drug costs.

Novo rolled out an easier-to-administer oral version of Wegovy earlier this year, betting that a more convenient, needle-free option could help attract new patients and bolster demand amid intensifying competition.

In a 72-week late-stage trial involving 1,407 obese adults without diabetes, participants on the 7.2-mg dose lost an average of 20.7% of body weight, compared with 17.5% for the 2.4-mg dose.

The approval reflects a step in the right direction for Novo, BMO Capital Markets analyst Evan Seigerman said, though he cautioned the company still faces an uphill battle as it fights to regain share from Lilly.

Novo Nordisk expects to launch the higher dose of Wegovy in a single-dose pen in the U.S. in April, and said it will announce the price then.

The higher dose is already approved in the UK as well as the European Union to be administered as three separate injections, while regulatory decisions on the single-dose pen are expected in the second half of 2026.