Novartis withdraws Vitravene MA in EU

Novartis Ophthalmics Europe, a division of Swiss drug major Novartis,has voluntarily withdrawn the European Union Marketing Authorization for Vitravene (fomivirsen), the first and only antisense drug on the market, for the local treatment of cytomegalovirus retinitis in patients with AIDS.

The MA was first issued in July 1999 and, in May this year, the company notified the European Commission of its intention to withdraw the drug, stressing that this was for commercial and not safety-related concerns. According to Novartis, the demand for Vitravene is less than 1000 units a year and so the firm does not believe the withdrawal will have any negative impact on patients in Europe.

In a press statement, the European Medicines Evaluation Agency noted that the drug is still authorized in Switzerland and that MA holder will still be able to supply Vitravene to EU member states from that country on a named patient basis.