CPMP backs approval of three new drugs

The European Commission's Committee for Proprietary Medicinal Productsissued positive opinions on three new therapeutics at its meeting on July 24-26, including:

- Novartis' Glivec (imatinib mesylate), which is indicated for the treatment of adult patients with Philadelphia chromosome (bcr-abl)-positive chronic myeloid leukemia in chronic phase after failure of interferon alfa therapy, or in accelerated phase or blast crisis. Glivec has been designated an orphan drug in the European Union, and was first approved for marketing in the USA earlier this year (Marketletter May 21);

- Merck Sharp & Dohme's caspofungin, a novel antifungal indicated for the treatment of invasive aspergillosis, which tends to occur in immunocompromized patients. The drug acts by inhibiting glucan polysaccharide synthesis in the cell wall of some pathogenic fungal species. The drug is marketed as Cancidas in the USA, where it was approved earlier this year (Marketletter February 5); and