Gilead's Vistide Cleared By CPMP

Gilead Sciences moved a step closer to having its novel antiviral drugVistide (cidofovir) approved throughout the European Union, following a positive recommendation by the Committee for Proprietary Medicinal Products. If approved by the European Medicines Evaluation Agency, Vistide will be marketed throughout the EU by Pharmacia & Upjohn.

Vistide, an intravenous nucleotide analog indicated for the treatment of cytomegalovirus retinitis in AIDS patients, was first launched in the USA in June, and has been well-received for its ease of administration compared to other intravenous antivirals. It is given once a week for two weeks for induction and once every other week for maintenance.

Once launched, Vistide will broaden P&U's AIDS franchise to complement Mycobutin (rifabutin) for opportunistic infections (tuberculosis and Mycobacterium avium complex). The company is also developing a non-nucleoside reverse transcriptase inhibitor, Rescriptor (delavirdine), which is awaiting its first regulatory approval (in the USA).