Merck Halts European Approval for Newly Acquired COPD Treatment

In a surprising strategic reversal, Merck has withdrawn the European Union marketing application for Ohtuvayre, the chronic obstructive pulmonary disease treatment it recently acquired through its $10 billion purchase of Verona Pharma. This decision comes just weeks after finalizing the acquisition, raising questions about the company's European regulatory strategy.

Merck formally pulled the EU marketing authorization application on October 30, 2025—a mere three weeks after completing the massive Verona Pharma takeover on October 7. The European Medicines Agency has confirmed the termination of the review process. Company representatives attributed this move to an ongoing "portfolio priority assessment."

The timing presents a significant puzzle for industry observers: why would Merck abandon European regulatory efforts so quickly after spending billions to acquire the therapy? The acquisition transaction provided Verona Pharma shareholders with $107 per depository share, with trading in the company's stock promptly discontinued following the deal's completion.

Strong US Launch Contrasts with European Setback

While European plans have been shelved, Ohtuvayre continues to demonstrate promising commercial performance in the United States. The treatment received FDA approval in June 2024 and launched commercially in August of the same year, with impressive early results:

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• $71.3 million in net sales during the first quarter of 2025
• Approximately 25,000 prescriptions filled in the same period
• First novel inhalation mechanism for COPD management in over two decades

The medication's unique approach combines bronchodilator and anti-inflammatory effects in a single formulation—a distinctive mechanism that originally attracted Merck's acquisition interest.

Strategic Repositioning or Regulatory Hurdle?

This European withdrawal represents Merck's first significant strategic shift regarding Ohtuvayre since assuming control. The pharmaceutical giant is currently integrating the COPD treatment into its cardio-pulmonary portfolio and must now reconsider its European market approach. Industry analysts are questioning whether this indicates a forthcoming change in regulatory strategy or reflects shifting market priorities within Merck's global expansion plans.

Despite this regional setback, the therapeutic potential of Ohtuvayre remains unquestioned. Merck continues to emphasize the drug's significant growth potential in addressing unmet medical needs among COPD patients. The timeline for European patient access—and indeed whether such access will materialize—now rests entirely with Merck's strategic decision-making.