Novo Nordisk files Wegovy product that claimed rapid voucher

Novo Nordisk has used the recently awarded FDA priority voucher for a high-strength version of its obesity drug Wegovy, setting up a possible approval within the next few weeks.

The Danish drugmaker is among the first recipients of the new Commissioner's national priority voucher (CNPV), a fast-track scheme launched by the FDA earlier this year for new medicines deemed to be of significance, for example because they address an unmet clinical need.

Under the CNPV scheme, a decision is expected within one to two months of the marketing application being accepted by the FDA.

Novo Nordisk received a voucher for a higher 7.2 mg injectable dose of semaglutide, the active ingredient in its Wegovy weight-loss brand, which it says offers "greater weight loss potential in adults with obesity."

Novo Nordisk is filing its supplemental new drug application (sNDA) for Wegovy 7.2 mg on the back of the phase 3b STEP UP obesity trial in more than 1,400 patients, with an average starting weight of 249 pounds (113 kg), which compared it to the standard 2.6 mg weekly dose or a matched placebo over 72 weeks.

Average weight loss was 20.7% with the 7.2 mg dose, with the 2.6 mg formulation achieving a 17.5% reduction and placebo a fall of 3.9% – based on patients who adhered to the weekly subcutaneous injections. The tolerability of the stronger version was said by Novo Nordisk to be "consistent" with the current formulation, although gastrointestinal side effects were more common.

"Our pipeline is rapidly expanding to meet the needs of people living with obesity, and this submission…marks an exciting step forward," said Anna Windle, head of clinical development, medical and regulatory affairs at Novo Nordisk.

"If approved, semaglutide 7.2 mg would bring patients and healthcare professionals a new option for greater weight loss potential, further underlining the efficacy that the semaglutide molecule can bring," she added.

It's worth noting that the topline weight reduction in STEP UP is roughly the same as the average weight loss achieved in clinical trials of Eli Lilly's rival obesity therapy Zepbound (tirzepatide), which helped patients shed 20.9% of their weight at the same 72-week time point in its pivotal trial, notwithstanding the well-recognised issues of trying to make comparisons between different studies.

Novo Nordisk is at risk of falling behind in the obesity market, as Zepbound's accelerating growth is coming at the same time as sales momentum is slowing for Wegovy, and the new formulation could be one way to turn that around. It is already under review in Europe with initial decisions due in the first quarter of next year.

While Novo Nordisk's CNPV was awarded for the new injectable strength, Lilly also claimed one for its oral GLP-1 agonist orforglipron, due to be filed before the end of 2025.

That will compete with Novo Nordisk's already-filed oral formulation of semaglutide, which is heading for a decision around the end of the year, potentially truncating its lead in what could be the next big growth area for weight-loss medicines.

Both companies have agreed with the Trump administration to reduce the prices of their GLP-1-based drugs for obesity and diabetes, as well as other products, in return for Medicare and Medicaid coverage.