The U.S. Food and Drug Administration (FDA) on Thursday approved a higher-dose version of Novo Nordisk A/S’ (NYSE:NVO) blockbuster weight-loss drug, Wegovy, marking an expansion of its treatment portfolio for adults with obesity.

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The approval comes via the Commissioner's National Priority Voucher (CNPV) expedited program.

The newly approved Wegovy HD (semaglutide) injection 7.2 mg is for patients who have already tolerated the currently approved 2.4 mg dose and require additional weight reduction.

The therapy is intended to be used alongside a reduced-calorie diet and increased physical activity.

Clinical Data From STEP UP Trial Supports Approval

The regulatory decision is based on results from the STEP UP clinical program, including a 72-week study evaluating the safety and efficacy of the 7.2 mg dose.

The trial enrolled 1,407 adults with obesity, defined as a body mass index ...