June 06, 2020

FDA approves new drug for MS

WASHINGTON — The first drug in 25 years for the direct treatment of multiple sclerosis was approved Friday by the Food and Drug Administration.

The new drug, called interferon beta 1B, is licensed by the FDA for treatment of patients who have the relapsing-remitting form of MS and who are able to walk.

Berlex Laboratories, a Richmond, Calif., firm that developed the drug, plans to market it under the brand name Betaseron.

An announcement from Berlex said the drug will be distributed in about two months and physicians will be notified when it is available for prescription. The company said the price of the drug will be announced at that time.

Multiple sclerosis is a degenerative disease in which it is believed the body’s immune system attacks myelin, a tissue that covers nerve fibers in the brain and spinal cord. The loss of myelin interferes with the normal signals in the central nervous system. No cure has been found.

Symptoms of the disease can range from very slight to crippling vision problems, muscle weakness, slurred speech and poor coordination.

MS usually strikes young adults, aged 20 to 40. About 300,000 Americans have the disease and nearly 200 new cases are diagnosed weekly, according to the National Multiple Sclerosis Society.

Three types of MS have been identified. The benign form of the disease is the mildest and may involve a single attack. The relapsing-remitting form follows a pattern of attacks and remissions. Chronic-progressive is the most severe form. In the most common course of the disease, patients move from relapsing-remitting to chronic-progressive.

Betaseron is licensed only for the treatment of relapsing-remitting MS. The exact mechanism of the drug’s action is not known, but in clinical trials Betaseron reduced the number and seriousness of relapses of MS.

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