Brand Name Drug: Novantrone
Active Ingredient Drug: mitoxantrone
Indication: Reduce the number of relapses and slow down disease progression in Multiple Sclerosis (MS)
Company Name: Immunex Corporation
Immunex submitted an NDA – New Drug Application – for Novantrone (mitoxantrone) on June 7, 1999 for a new multiple sclerosis (MS) indication, and it was granted “priority review” status on July 17, 1999. Novantrone was initially indicated for the treatment of patients with pain due to advanced hormone-refractory prostate cancer. It can also be used as a component of combination therapy for acute nonlymphocytic leukemia in adults.
How it Works
Novantrone (mitoxantrone) slows disease progression in MS and lessens the number of relapses through its ability to suppress the activity of T cells and B cells. These white blood cells attack the myelin that protects nerve cells, and by doing so cause the symptoms of Multiple Sclerosis.
Novantrone (mitoxantrone): Clinical Study Results
A multi-center, placebo-controlled, randomized, observer-blind study was conducted to evaluate the effects of Novantrone 12 mg/m2 and 5 mg/m2 on attacks and disease progression. Disease progression was assessed using the Expanded Disability Status Scale (EDSS). Patients were administered 12 mg/m2, 5 mg/m2, or placebo as IV infusion once every three months for two years. Follow-up studies conducted one year after treatment demonstrate the efficacy of Novantrone in reducing the number of attacks and slowing disease progression. 17% (12 mg/m2 dose) and 24% (5 mg/m2 dose) of patients experienced a deterioration measured as one point on the EDSS scale compared to 44% of patients in the placebo group. The mean number of relapses were 0.48, 0.42, and 0.74 for patients who were administered 12 mg/m2 Novantrone, 5 mg/m2 Novantrone, and placebo, respectively. Compared to 51% of the placebo group, 66% and 69% of the 12 mg/m2 Novantrone and 5 mg/m2 Novantrone groups, respectively, remained without relapse one year after treatment.
What the Patient Should Know
Possible adverse events are nausea, hair loss, urinary tract infection, and menstrual disorder. Novantrone for Multiple Sclerosis is administered intravenously once every three months, in contrast to currently prescribed MS therapies that require daily or weekly subcutaneous or intramuscular injection.