Press Release: Rare diseases: Commission authorises drug for treatment of chronic myeloid leukaemia

The European Commission granted a Marketing Authorisation for a drug expected to benefit patients suffering from chronic myeloid leukaemia on 8 November 2001. Chronic myeloid leukaemia is estimated to affect approximately 0.9 in 10,000 i.e. less than 337,500 people in the European Union. The prevalence of this disease thus falls well within the criteria for the grant of orphan (rare disease) status. This product, Glivec, contains the active substance imatinib mesilate and will be available in the 15 EU Member States. As a designated orphan medicinal product, under EU rules, it will be entitled to 10 years of market exclusivity