New drug shows promise in multiple sclerosis treatment, researchers say FDA approves new multiple sclerosis treatment Aubagio Commonly prescribed interferon beta does not delay multiple sclerosis progression in study
Each week 200 or more Americans are diagnosed with multiple sclerosis, according to the National Multiple Sclerosis Society. The autoimmune disease causes the body's natural defenses to attack the central nervous symptom, resulting in symptoms that range from mild, including numbness in the limbs, to severe symptoms like disability, loss of vision or paralysis. Most people are diagnosed between 20 and 50, NMSS says.
There are four types of MS, with 85 percent of patients initially diagnosed with what's called relapsing-remitting MS. People with relapsing-remitting MS often have attacks - called relapses, flare-ups or exacerbations - that may worsen neurological function, which are followed by partial or complete recovery (remission) periods.
The trials for BG-12 were phase III, which is often the step closest to a drug's approval when scientists gather more data on its safety and efficacy. BG-12 is manufactured by Massachusetts based-Biogen Idec, which is seeking FDA approval on the drug. The drugmaker funded the new studies, which were published online Sept. 20 in the New England Journal of Medicine.
The first study - known as the DEFINE trial - looked at 1,200 people to determine whether a BG-12 pill could reduce the frequency of relapses compared to people with MS who were taking a placebo pill.
Participants were split into three groups: those taking 240 milligrams of the pill twice a day, those taking 240 milligrams three times a day and those taking a placebo. At two years, both groups taking BG-12 experienced significant reductions in relapses (49 percent and 50 percent reductions respectively) compared with placebo-takers.
Taking BG-12 also led to significant reductions in risk of MS progressing to disability for the patients. MRI scans confirmed pill-takers had fewer new or active MS lesions than scans of people taking placebo.
The next trial, led by Dr. Robert J. Fox, medical director at the Cleveland Clinic's Mellen Center for Multiple Sclerosis, included 1,400 people with MS to determine whether BG-12 could reduce the average yearly relapse rate for patients at two years.
Similar to DEFINE, this study - known as the CONFIRM trial - measured relapse rates of patients taking either a 240 milligram dose of BG-12 twice a day or three times a day, comparing them a group taking placebo. A fourth group was assigned to receive the injectable MS drug, glatiramer acetate, which is sold as Copaxone and was FDA-approved in 1996 to reduce the frequency of relapses in patients with relapsing-remitting MS.
Continued here:
Experimental multiple sclerosis pill reduces flare-ups in studies, adding hopes for new treatment option
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