Sequus On Track For Euro Approval Of Doxil

California, USA-based Sequus Pharmaceuticals Inc says it has received a unanimous opinion from the European Committee on Proprietary Medicinal Products recommending approval in all 15 European Union member countries of its anticancer drug doxorubicin in its long-circulating Stealth liposome formulation. In Europe, the trade name will be Caelyx, while it is already marketed in the USA as Doxil.

The CPMP has recommended use of the drug for both first-line and second-line treatment of AIDS-related Kaposi's sarcoma in patients with low CD4 counts and extensive mucocutaneous or visceral disease. The CPMP also recognized the use of the European trade name.

Sequus' vice president for regulatory affairs. Carl Grove, commented that this positive opinion, which is binding on all EU member states, "is a landmark event in terms of obtaining marketing approval throughout Europe and making our drug available to European patients suffering with KS disease."