Novo Nordisk Secures Dual EU Regulatory Wins: Wegovy Pill and High-Dose 7.2 mg Injection both Recommended for Approval

On May 22, 2026, the EMA's Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on two major Novo Nordisk regulatory submissions in a single day — both wins that will expand Novo's commercial footprint in the EU in H2 2026.

Wegovy® Pill (Oral Semaglutide 25 mg)

The CHMP recommended marketing authorization for the Wegovy pill as the first oral GLP-1 weight management treatment in the EU. Key details:

• 16.6% mean weight loss (efficacy estimand) in the OASIS 4 trial
• One in three patients achieved ≥20% weight loss
• The label includes SELECT cardiovascular outcomes data showing MACE risk reduction
• Notably, the label has no drug-drug interaction restrictions — a competitive advantage over some oral GLP-1 alternatives
• CEO Mike Doustdar noted: "More than 1 million Americans began using Wegovy pill within the first four months following launch"

"We are encouraged by CHMP's positive opinion for Wegovy pill, bringing the most efficacious oral GLP-1 in its class one step closer to becoming the first approved oral treatment in its class for weight management in the EU." — Mike Doustdar, CEO, Novo Nordisk (Company Announcement, May 22, 2026)

Wegovy® 7.2 mg Single-Dose Pen (Wegovy HD)

The CHMP also recommended approval of the higher-dose 7.2 mg Wegovy injection in a single-dose pen. This is already approved in the US (as Wegovy HD) and the UK. STEP UP trial results:

• 20.7% mean weight loss at 72 weeks (efficacy estimand)
• 31.2% of patients achieved ≥25% weight loss
• STEP UP T2D showed 14.1% weight loss in patients with obesity + type 2 diabetes
• EU launch expected in Q3 2026

"With Wegovy 7.2 mg now recommended for approval in the single-dose pen, people with obesity can reach their weight and health goals through a convenient, easy-to-use pen." — Mike Doustdar (Company Announcement, May 22, 2026)

Investor implications: These EU wins materially expand Novo's addressable market at a time when the stock (down ~32% over the past year) desperately needs positive catalysts. The EU obesity market is large and relatively underserved. Oral Wegovy's no-restriction label is a clear differentiator vs. orforglipron in Europe. However, European pricing is typically far lower than US pricing, so revenue per patient will be smaller.