BI's Spiriva cleared for COPD in EU

21 April 2002

Boehringer Ingelheim of Germany's muscarinic M3 receptor antagonistSpiriva (tiotropum) has been approved in the European Union as a once-daily bronchodilator for the treatment of chronic obstructive pulmonary disease. The clearance of the drug in the EU follows mutual recognition of its approval in the Netherlands. It is also registered in New Zealand, the Philippines, Slovakia and Mexico, and is under review in the USA.

The label in the EU notes that Spiriva is superior in controlling breathlessness/dyspnea in COPD patients to ipratropium, BI's existing product for this indication. The German firm and its marketing partner for Spiriva, Pfizer, said that launches of the new drug are expected to take place by the middle of this year. BI recently predicted that peak sales of Spiriva could reach 2 billion euros ($1.75 billion; Marketletter April 15).

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