Boehringer Ingelheim's Spiriva approved in first market, the Netherlands

Boehringer Ingelheim of Germany has been granted approval by theMedicinal Evaluation Board of the Netherlands for Spiriva (tiotropium), the firm's new drug for the treatment of chronic obstructive pulmonary diseases such as chronic bronchitis and emphysema.

This marks the first worldwide approval of the drug, which is also the first once-daily, inhaled therapy for COPD. An additional registration in New Zealand is expected in the near future, said the firm. Meantime, a marketing application in the USA should be made later this year, and approval in this market will be vital if Spiriva is to fulfil its promise as a potential blockbuster, with peak sales in excess of $1 billion a year.

BI licensed worldwide co-marketing rights for Spiriva earlier this year to Pfizer (Marketletter April 23), and sees the new drug as a key growth driver in the next few years. Indeed, COPD is an established indication for the German firm, as its two best-selling drugs, Atrovent (ipratropium) and Combivent (ipratropium and albuterol) both target this disease.