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European Committee Votes In Favour Of Vitravene For Advanced CMV Retinitis CARLSBAD, CA -- April 28, 1999 -- The Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA) have issued a positive opinion to approve the marketing application for Vitravene™ (fomivirsen) as a second-line treatment for cytomegalovirus (CMV) retinitis in patients with AIDS. Vitravene was developed by Isis Pharmaceuticals, Inc. CIBA Vision, the eye care unit of world life sciences leader, Novartis AG, holds exclusive worldwide distribution rights to market the drug. The marketing authorization application was filed in April, 1998. The Committee recommended that until further experience is gained, Vitravene™ be approved for use in the local treatment of CMV retinitis in newly diagnosed or advanced CMV retinitis when other therapies are considered unsuitable or have been ineffective. Vitravene™ is an antisense inhibitor of CMV replication, the virus that causes retinitis. CMV retinitis is a degenerative opportunistic infection that affects people with AIDS and results in blindness. Vitravene™ is the first antisense drug to be filed for commercial marketing review. Vitravene™ received approval for marketing in the United States in August, 1998. "We are pleased that the committee recognizes the benefits of Vitravene™ in providing patients with an additional treatment option for CMV retinitis and especially pleased that the committee recommended Vitravene™ for both newly diagnosed and advanced patients," said Stanley T. Crooke, Chairman and CEO of Isis Pharmaceuticals. "Assuming that the European Commission follows the CPMP recommendation, it will provide European patients and physicians with a new therapy with proven effectiveness against this disease." E-mail this page to a friend or colleague! To print, use this version