Novo Nordisk's Strategic Move to Expand Wegovy's Market Potential: Assessing the Competitive and Financial Implications of FDA Approval for the 7.2 mg High-Dose Injection

Novo Nordisk's recent submission of a supplemental New Drug Application (sNDA) for a 7.2 mg dose of Wegovy (semaglutide) to the U.S. Food and Drug Administration (FDA) marks a pivotal moment in the company's strategy to solidify its leadership in the obesity drug market. Filed on November 26, 2025, the application is under review via the FDA's Commissioner's National Priority voucher (CNPV) pilot program, which accelerates approvals for therapies addressing critical public health needs. A decision is expected within 1–2 months after acceptance, with the potential to unlock significant competitive and financial advantages for Novo Nordisk.

Competitive Landscape: Efficacy, Pricing, and Market Share

The 7.2 mg dose of Wegovy, supported by the STEP UP phase 3 trial, demonstrated an average weight loss of 20.7% over 72 weeks, outperforming the 17.5% loss seen with the 2.4 mg dose and 2.4% with placebo. This improvement positions the higher dose as a compelling alternative to Eli Lilly's Zepbound (tirzepatide), which, in head-to-head trials, achieved 20.2% weight loss but required higher doses and carried a steeper price tag. While Zepbound's dual hormone-targeting mechanism has shown superior efficacy in some studies, Novo Nordisk's broader pharmacy access—70,000 U.S. locations—could offset this edge by improving patient accessibility.

Pricing remains a key battleground. Wegovy's cash-pay price of $349/month for maintenance doses aligns with Zepbound's starting dose, but higher Zepbound doses remain at $499/month. Novo's strategy of preemptive price reductions and expanded access appears designed to capture market share in the cash-pay segment, where affordability is a growing concern. However, Zepbound's weekly prescription volume has consistently outpaced Wegovy's in recent months, reflecting its entrenched position.

Financial Implications: Revenue Growth and Market Dynamics

Wegovy has already proven to be a blockbuster for Novo Nordisk, with sales reaching $5.41 billion in the first half of 2025—a 78% year-over-year increase. The 7.2 mg dose could further bolster this trajectory, particularly given its demonstrated efficacy. However, analysts note a slowdown in growth momentum, with Novo Nordisk revising its full-year 2025 sales growth guidance to between 8% and 11% from earlier projections of 11%. This adjustment reflects intensifying competition, pricing pressures, and supply chain challenges.

Third-quarter 2025 results underscore these dynamics: Wegovy sales grew 23% to DKK 20.35 billion but fell short of analyst expectations of DKK 21.35 billion. While the 7.2 mg dose's approval could drive incremental revenue, its impact will depend on Novo's ability to differentiate Wegovy in a crowded market. The company's pipeline, including oral semaglutide and combination therapies like CagriSema, may also play a role in sustaining long-term growth.

Strategic Considerations for Investors

The approval of the 7.2 mg dose represents a calculated risk for Novo Nordisk. On one hand, it strengthens Wegovy's value proposition by offering a higher-efficacy option, potentially attracting patients who may have switched to Zepbound. On the other, it faces the challenge of maintaining margins amid aggressive pricing strategies and regulatory scrutiny. The CNPV expedited review offers a critical window to capitalize on market momentum before Zepbound's dominance in prescriptions solidifies further.

For investors, the key variables will be the FDA's decision timeline, post-approval uptake of the 7.2 mg dose, and Novo's ability to navigate pricing pressures. While the STEP UP trial data is promising, real-world adoption will hinge on factors such as insurance coverage, patient tolerance for side effects, and the broader economic environment.

Conclusion

Novo Nordisk's push for FDA approval of the 7.2 mg Wegovy dose underscores its commitment to maintaining a leadership role in the obesity drug market. The higher dose's efficacy, combined with strategic pricing and distribution advantages, positions it as a strong contender against Zepbound. However, the company must contend with a rapidly evolving competitive landscape and the financial realities of a market where affordability and access are paramount. If approved, the 7.2 mg dose could reinvigorate Wegovy's growth trajectory—but its long-term success will depend on Novo's ability to adapt to shifting dynamics and sustain innovation.