Novo Nordisk Seeks Extra-Fast Nod From FDA for Higher Dose of Wegovy

Novo Nordisk NVO announced that it has submitted a regulatory filing seeking label expansion for a higher dose of its blockbuster obesity drug, Wegovy (injectable semaglutide).The FDA filing seeks approval for a 7.2 mg dose of the drug, which Novo Nordisk claims provides an option for “greater weight loss potential” than what is currently being offered by the available doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg).For this filing, Novo Nordisk is seeking an extra-fast review through the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program. This program is designed to significantly fast-track the review of drugs and biologics addressing serious or life-threatening diseases with high unmet medical needs, reducing the standard review period from 10-12 months (6-8 months in case the drug is granted priority review designation) to just 1-2 months. The CNPV voucher was granted to the company by the agency earlier this month.How Effective is NVO’s Higher-Dose Wegovy?The filing is supported by data from the phase III STEP UP study, which showed that participants who took a 7.2 mg dose of Wegovy for 72 weeks achieved an average weight loss of 20.7% compared with 2.4% with placebo and 17.5% with a 2.4 mg Wegovy dose.Novo Nordisk also reported additional analyses from the study, which showed that 33.2% of people who took the 7.2 mg dose achieved a weight loss of at least 25% compared with 16.7% of participants in the 2.4mg dose group. No patients in the placebo arm met this criterion.A similar regulatory filing is currently under review with the EMA, also supported by data from the STEP UP study. A final decision is expected in the first quarter of 2026.NVO Stock PerformanceYear to date, shares of Novo Nordisk have plunged over 43% against the industry‘s 19% growth.Image Source: Zacks Investment ResearchKey Developments Around NVO’s Obesity DrugsThis week has been mixed for Novo Nordisk, which reported several key updates around its pipeline. While the company’s investigational oral obesity pill called amycretin achieved significant weight loss and HbA1c reduction in type 2 diabetes (T2D), two late-stage studies on Rybelsus (oral semaglutide) failed to show superiority over placebo in reducing progression of Alzheimer’s disease (AD).Earlier this week, the Centers for Medicare & Medicaid Services announced that it has negotiated price reductions for 15 drugs that will be applicable from 2027. One of these 15 drugs is Novo Nordisk’s semaglutide products, which will be sold at a negotiated price of $274 per month, a 71% discount to its 2024 list price.Beyond Wegovy, semaglutide is also marketed as Ozempic (for T2D). Recently, the company secured approval for an oral version of semaglutide, which is marketed under the name Rybelsus in the T2D indication.Competition Heating Up in the Obesity SpaceAccording to research conducted by Goldman Sachs, the obesity market in the United States is expected to reach $100 billion by 2030. Novo Nordisk and Eli Lilly LLY currently dominate this space.Wegovy directly competes with Eli Lilly’s tirzepatide medicine Zepbound. Like Novo Nordisk, LLY also generates a substantial portion of its revenues from sales of this drug.NVO and LLY are racing to introduce oral weight-loss pills. Novo Nordisk has already submitted a regulatory filing with the FDA seeking approval for an oral version of Wegovy, with a final decision expected before this year’s end. Apart from amycretin, NVO is also developing another next-generation candidate in its obesity pipeline called CagriSema (a combination of semaglutide and cagrilintide).Eli Lilly is investing broadly in next-generation drugs and is currently developing a range of oral and injectable medications with different mechanisms of action. This includes two late-stage candidates, orforglipron, a once-daily oral GLP-1 small molecule and retatrutide, a GGG tri-agonist. LLY remains on track to submit regulatory filings for orforglipron in obesity before this year’s end, setting up the timeline for a potential launch next year. Like Novo Nordisk, Eli Lilly also secured a CNPV from the FDA for orforglipron earlier this month.Several other companies, including Viking Therapeutics VKTX, are also advancing obesity candidates. In June, VKTX started two late-stage studies evaluating the subcutaneous formulation of its investigational obesity drug, VK2735. While one of these studies recently completed enrolment at a rapid pace, Viking Therapeutics expects to complete enrolment in the other study by the first quarter of 2026.Earlier this month, Pfizer PFE closed the acquisition of obesity drug developer Metsera for around $10 billion, after a heated bidding war against Novo Nordisk. The Metsera acquisition has brought Pfizer back into the lucrative obesity space by adding the latter’s four novel clinical-stage incretin and amylin programs, which are expected to generate billions of dollars in peak sales.Novo Nordisk A/S Price  Novo Nordisk A/S price | Novo Nordisk A/S QuoteNVO’s Zacks RankNovo Nordisk currently carries a Zacks Rank #3 (Hold). 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(VKTX): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks