News flash: Novantrone is near approval for MS

News flash: Novantrone is near approval for MS – multiple sclerosis

At a hearing on January 28, an FDA advisory committee reviewed the results of clinical trials of Novantrone and unanimously recommended that the agency approve it for marketing in the U.S. to slow worsening associated with secondary-progressive and relapsing MS. The FDA is expected to finalize approval shortly. If they do, it will be the first drug ever approved in the U.S. for secondary-progressive MS.

The powerful immune-suppressing drug is taken intravenously once every 3 months for about 2 years. Data indicate that Novantrone can slow down disease worsening and may thus forestall increases in disability.

Clinical trials in people with MS and in people with some forms of cancer for which Novantrone has already been approved show that it has significant side effects. These include hair loss, nausea, and, in women, menstrual problems. Morever, cumulative doses may eventually result in heart damage, so the drug will likely require close monitoring for heart function and may require a cap after about 2 years of treatment.

Secondary-progressive MS develops after a number of years in which people have relapsing-remitting MS with clear-cut attacks (or exacerbations) followed by partial or complete recovery. Approximately half of all people with relapsing-remitting MS eventually develop secondary-progressive MS. At that point their recoveries are only partial and they lose abilities gradually but steadily.

The Summer issue of InsideMS will have more information on progressive MS and treatment approaches now on the horizon.

COPYRIGHT 2000 National Multiple Sclerosis Society

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