A new oral medication to treat patients in the early stages of multiple sclerosis has shown considerable promise in two clinical trials, researchers announced Wednesday.
The medication is on track to become just the third oral drug available to MS patients, and potentially the safest and most effective, experts said. The second oral drug, called Aubagio, was approved just last week.
MS was virtually untreatable only two decades ago, but today nine ‘‘disease-modifying’’ drugs are available for early stage patients, and a half-dozen more are in the late stages of development. Most patients in the early stage of the disease, a form called relapsing-remitting MS, take drugs intravenously.
The two new studies, published online in The New England Journal of Medicine, found that the drug BG-12, developed by Biogen Idec, reduced relapse rates in patients with relapsing MS by about 50 percent. The drug also significantly reduced the frequency of new brain lesions often associated with these attacks, and slowed the progression of disease compared with a placebo.
The studies were Phase 3 trials, a last step on the road to drug approval. The Food and Drug Administration is required to make a decision about the drug’s approval before the end of this year.
‘This drug is . . . quite effective in managing disease and reducing disability.’
“This drug is clearly quite effective in managing disease and reducing disability, and the safety profile looks quite good,’’ said Timothy Coetzee, the chief research officer at the National Multiple Sclerosis Society.
Multiple sclerosis is often a progressive disease in which the immune system damages neurons in the brain and spinal cord.
A majority of people with MS have relapsing-remitting MS, characterized by flare-ups that cause lesions in the brain to develop and neurological symptoms to emerge or worsen. Eventually, more than half of patients develop a progressive form of MS, leading to permanent disabilities.
Interferons, the drugs most commonly used in relapsing MS, reduce relapses by about 30 percent, and have not been shown to slow the progression of the disease and disability.
Sanofi’s newly approved Aubagio also reduces relapses by about 30 percent, and it has the advantage of being an oral drug.
Two drugs that are substantially more effective, Biogen’s Tysabri and Novartis’s Gilenya, come with serious risks. They are used as second-line treatments when an initial approach fails, and patients require careful monitoring while taking them.