European Approval for Vitravene
The Committee for Proprietary Medicinal Products of the European Medicines Evaluation Agency has recommended approval of the marketing authorization application (MAA) of Vitravene (fomivirsen) for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. Vitravene is an antisense compound developed by Isis Pharmaceutical (2292 Faraday Ave., Carlsbad, CA 92008; Tel:
760/931-9200, Fax: 760/931-9639) for which CIBA Vision Corp. holds exclusive worldwide distribution rights. CIBA Vision, the eye care unit of Novartis AG, filed the MAA in April, 1998.
Until further experience is gained, the committee recommended that Vitravene be approved for use in the treatment of CMV retinitis only when other therapies are considered unsuitable or have proved ineffective. Vitravene is an inhibitor of CMV replication. CMV retinitis is a degenerative opportunistic infection that affects people with AIDS and may result in blindness. Vitravene is the first antisense drug ever reviewed for commercial distribution. The drug received approval for marketing in the U.S. 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,” says Stanley T. Crooke, chair and CEO of Isis Pharmaceuticals.
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