Novo Nordisk Gets U.S. Approval for Weight-Loss Pill

• Clinical trials showed 16.6% average weight loss over 64 weeks versus 2.7% for placebo, targeting 40% of American adults who are obese
• Pill addresses injection hesitancy and travel convenience issues, with analysts expecting oral medications to capture about one-fifth of the GLP-1 market
• Novo faces competition from Lilly's orforglipron pill expected in March, which doesn't require the 30-minute fasting period before consumption

Novo Nordisk Gains FDA Approval for Oral Weight-Loss Pill

The FDA approved Novo Nordisk's oral weight-loss medication on Monday, marking a significant advancement in the obesity treatment market. The 25mg semaglutide pill, marketed under the Wegovy brand, represents the first oral GLP-1 weight-loss medication to receive U.S. approval.

Key Clinical Data:

• Participants lost an average of 16.6% of body weight over 64 weeks, versus 2.7% for placebo
• Approved for adults with obesity or overweight with at least one related health condition
• 40% of American adults are obese; 12% currently take GLP-1 drugs

Market Positioning:

Novo seeks to regain market share from rival Eli Lilly, whose injectable Zepbound currently leads weekly U.S. prescriptions. The oral formulation addresses injection hesitancy and could expand the patient pool in a global market projected to reach $150 billion annually by next decade. Analysts estimate pills could capture approximately 20% of the market.

Pricing Strategy:

• Starter doses: $149/month for Medicare/Medicaid and cash-paying customers via TrumpRx
• Recently reduced Wegovy injection price to $349/month (from $499)
• Standard U.S. list prices exceed $1,000/month

Competitive Landscape:

While Novo has first-mover advantage with oral semaglutide, challenges remain. The pill requires morning administration on an empty stomach, 30 minutes before eating or drinking. Lilly's oral candidate orforglipron, potentially approved by late March, has no such restrictions.

Manufacturing occurs in North Carolina, with Novo building supplies "for some time" to avoid the shortage issues that plagued their injectable launch. The 1.5mg starter dose becomes available in early January, positioning Novo to capitalize on renewed market momentum after a challenging year of declining U.S. market share.