Novantrone® (mitoxantrone)

• Parent company: EMD Serono, Inc.


• Given via intravenous infusion once every three months for a maximum of two-to-three years. The total dose that can be taken is limited to avoid the risk of damage to the heart. Careful monitoring both during and after treatment is necessary. Dose varies according to an individual's weight.


• It is approved for use in secondary-progressive MS (SPMS), progressive-relapsing MS (PRMS), worsening RRMS, and for people who are not responding favorably to standard therapies.


• The drug delays the time to a first treated relapse, reduces the number of relapses, delays the time to disability progression, and decreases the number of new lesions that can be detected by MRI.


• Novantrone is an immunosuppressant that has been used for years to treat cancer. It targets rapidly dividing cells, including those believed to be involved in MS.


• Preliminary evidence suggests that low-dose Novantrone may be used as an add-on rescue therapy in RRMS patients who respond poorly to interferon-beta treatment. The anti-inflammatory response was evident after six months.


• Researchers suggested that the therapy was well-tolerated and may reduce the risk of adverse events seen with higher doses of Novantrone.


• An ongoing study of safety and tolerability is collecting data about Novantrone therapy. The 500 patients in the study will be assessed over five years, with the primary outcome measures being the incidence of symptoms of adverse events.


• Combination and Comparative studies:
  A study to evaluate the use of Novantrone as an induction agent before Copaxone treatment, versus treatment with Copaxone alone, found beneficial results as measured by annual relapse rates in the Novantrone-induced group.