RegulatoryMay 22, 2026, 10:07 AM
Novo Nordisk's Wegovy® Pill Recommended for EU Approval by CHMP
AI Summary
Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorization for Wegovy® pill (oral semaglutide 25 mg) in the EU. This marks the first oral GLP-1 treatment recommended for weight management in the EU, demonstrating a mean weight loss of 16.6% in the OASIS 4 trial. The recommendation also includes data showing Wegovy® reduces the risk of major adverse cardiovascular events (MACE) and notes no drug-drug restrictions. Novo Nordisk anticipates launching the Wegovy® pill in select markets outside the US in the second half of 2026.
Key Highlights
- CHMP recommends Wegovy® pill for approval in EU for weight management.
- Wegovy® pill demonstrated 16.6% mean weight loss in OASIS 4 trial.
- One in three people experienced 20% or greater weight loss in OASIS 4 trial.
- Recommendation includes SELECT data showing Wegovy® reduces major adverse cardiovascular events (MACE).
- Wegovy® pill is the first oral GLP-1 treatment recommended by CHMP for weight management in the EU.
- The label includes no drug-drug restrictions with concomitant medications.
- Novo Nordisk plans to launch Wegovy® pill in select markets outside the US in H2 2026.
- Over 1 million Americans started using Wegovy® pill within four months of its US launch.
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