FDA Approves Bayer HealthCare's Betaseron to Treat Relapsing Forms of Multiple Sclearosis

BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and is shown to delay the progression to clinically definite MS (CDMS) when used from the first event suggestive of MS.

BETASERON is a type of protein called interferon.

Interferons occur naturally in the body. They are signaling proteins that the cells in your body use to communicate with one another. Interferons are key communicators in the immune system.


The only multiple sclerosis treatment that has been available to patients for almost 20 years,
A pioneer as the first FDA approved disease-modifying therapy for relapsing forms of multiple sclerosis,
The longest studied multiple sclerosis treatment with over 20 years of clinical and safety data.

Betaseron is an interferon beta medication used to treat the relapsing-remitting form of multiple sclerosis (MS). This medication is not a cure for MS, but may decrease the number of times an individual relapses as well as delay the progression of the disease when used at an early stage.

The Food and Drug Administration today announced the licensing of Interferon beta-1b, the first product for the treatment of certain patients with multiple sclerosis and the first biotechnology product to be licensed under FDA's accelerated approval regulations.
Multiple sclerosis is a chronic, often disabling disease of the central nervous system that occurs when a protective sheath surrounding the nerve fibers breaks down. Nearly 30 percent of multiple sclerosis patients suffer from a relapsing-remitting form of the disease in which symptoms disappear totally or partially after a flare-up and are followed by a period of stability that can last for months or years

In July of 1993, the FDA approved interferon beta-1b (Betaseron®) for relapsing-remitting MS to reduce the frequency of clinical relapses. Betaseron? works by reducing the ability of inflammatory cells of the immune system to enter the central nervous system. Betaseron® is given by subcutaneous injection (under the skin) every other day and was found in clinical trials to reduce relapses by about 30% and severe relapses by about 50%. In addition, it reduced new lesion formation within the central nervous system as seen on MRI. In 2004 the FDA approved the drug for use in more progressive patients still having relapses. Although it is not a premixed solution, it can be stored at room temperature and can be given with an auto-injector device.