EU recommends Daxas approval following FDA panel rejection

Nycomed is in luck. The European Medicines Agency today recommended approval of Daxas, the company's once-a-day pill for patients with severe COPD. The approval follows an expert FDA panel's decision earlier this month not to recommend the drug for approval. In a 10-5 vote, panelists determined the side effects of Daxas outweighed the limited improvement in lung function. The ruling was a blow to Nycomed's partner Forest Labs, which has U.S. rights to Daxas. A final FDA decision is due in May.

Nycomed says it will launch Daxas later this year once it obtains a formal approval from the European Commission. The drug's approval there could lead to an IPO for Nycomed, which has planned to go public but never provided a timetable for doing so. "Nycomed is excited about the positive opinion of the CHMP recommending approval of Daxas in the European Union. Daxas is the first in a new class of oral agents to treat this life-threatening condition, offering clinicians and patients a much needed new treatment option alongside existing inhaled therapies," said Anders Ullman, Nycomed executive vice president of R&D.

- here's Nycomed's release on the approval
- read more from Reuters

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