FDA Priority Vouchers Impact Analysis: Lilly and Novo Nordisk Obesity Drug Strategy

This analysis is based on the Fierce Biotech report [1] published on November 6, 2025, which reported that the FDA awarded national priority review vouchers to Eli Lilly and Novo Nordisk for their obesity treatments. The announcement coincided with a White House press conference where both companies’ executives unveiled pricing agreements to reduce obesity drug costs for government programs and cash-paying patients [1][2]. The market reaction has been notably divergent, with Lilly’s stock surging while Novo Nordisk’s declined, reflecting different competitive dynamics and recent strategic developments.

The FDA’s national priority voucher program, launched in June 2025, represents a significant shift in drug review processes, reducing typical review times from 10-12 months to just 1-2 months for medicines aligned with U.S. national priorities [1]. Both companies received these vouchers for different products:

• Lilly’s orforglipron
  : An oral GLP-1 candidate expected to gain approval in Q1 2026 [2]
• Novo Nordisk’s Wegovy
  : A “slightly different version” of the existing semaglutide injection [1]

The accompanying White House pricing agreement establishes new cost structures:

• Starter doses: $149/month for government programs and cash payers
• Injectable GLP-1s: $245/month for Medicare/Medicaid patients
• Lilly’s Zepbound: $299-$449/month depending on dosage [2]

The stock market reaction reveals starkly different trajectories for the two obesity giants:

• Current price: $45.68 (-1.78% on November 8) [0]
• 30-day performance: -15.63% decline from $54.14 to $45.68 [0]
• Trading near 52-week lows of $45.05 [0]

• Current price: $924.37 (-1.39% on November 8) [0]
• 30-day performance: +27.40% surge from $725.55 to $924.37 [0]
• Trading near 52-week highs of $955.46 [0]

The divergent market performance reflects underlying competitive differences. Novo Nordisk’s recent decline appears more closely tied to losing the $10 billion bidding war for obesity drug developer Metsera to Pfizer [3]. Multiple sources indicate Novo withdrew after Metsera’s board accepted Pfizer’s higher offer, citing antitrust regulatory concerns [3][4].

Conversely, Lilly’s strength is supported by:

• Potential first-mover advantage with oral orforglipron approval in Q1 2026 [2]
• A separate $1.2 billion RNAi therapeutics deal with SanegeneBio [5]
• Deutsche Bank estimates that $150 monthly pricing could unlock access for up to 15 million Americans [2]

The priority voucher awards create asymmetric advantages. Lilly’s oral formulation could reach market before Novo’s oral Wegovy, potentially establishing crucial first-mover advantages in the oral GLP-1 segment [2]. The pricing structure, while creating margin pressure for both companies, may disproportionately benefit Lilly if orforglipron gains market share quickly.

The pricing agreements represent a strategic trade-off between margin preservation and market expansion. Deutsche Bank’s analysis suggests the $150 monthly price point could dramatically expand patient access [2], potentially creating a larger overall market despite lower per-patient revenue.

The accelerated review process carries inherent risks. Consumer advocacy groups like Public Citizen have criticized the program for potentially compromising safety through faster reviews [1]. Legal experts also suggest the selection criteria could face litigation challenges [1], creating uncertainty around the long-term viability of these regulatory advantages.

• Margin Compression
  : The pricing agreements will impact profitability, with Novo explicitly warning of “low single-digit negative impact” on 2026 global sales growth [2]
• Regulatory Scrutiny
  : Accelerated approvals may face increased safety monitoring and potential post-approval requirements
• Legal Challenges
  : The priority voucher program faces potential litigation over selection criteria [1]

• Novo Nordisk
  : Loss of Metsera acquisition combined with potential second-mover disadvantage in oral GLP-1 market could erode market share [3][4]
• Eli Lilly
  : Execution risk in rapidly bringing orforglipron to market while maintaining quality standards

• Lilly’s potential Q1 2026 approval could establish early market leadership in oral GLP-1s [2]
• Three-year tariff exemptions provide cost advantages for both companies [2]

• Expanded patient access through government programs could create sustainable market growth
• Priority review experience could accelerate future pipeline development

1. Approval Timelines
   : FDA decisions on oral formulations will be critical catalysts
2. Market Share Dynamics
   : Prescription trends after pricing implementation
3. Competitive Developments
   : Pfizer’s integration of Metsera and potential new entrants
4. Safety Monitoring
   : Any adverse events with accelerated approvals could impact the entire program
5. Pricing Sustainability
   : Long-term viability of reduced pricing structure amid rising costs

The FDA’s priority voucher awards to Lilly and Novo Nordisk represent a significant regulatory development that could reshape the obesity treatment landscape. However, the market’s divergent reaction suggests investors are weighing different competitive factors beyond the regulatory benefits [0].

Novo Nordisk’s recent decline appears more influenced by the loss of the Metsera acquisition to Pfizer [3][4], while Lilly’s surge reflects optimism about potential first-mover advantage with oral orforglipron [2]. The pricing agreements, while creating margin pressure, could significantly expand market access and overall market size.

Both companies face execution challenges in balancing rapid development with safety requirements, while navigating the regulatory and legal uncertainties surrounding the priority voucher program [1]. The coming months will be critical in determining whether the regulatory acceleration translates into sustainable competitive advantages.