Sanofi To Appeal FDA’s Rejection Of Lemtrada, Multiple Sclerosis Drug

• Lemtrada is currently used in Europe, Canada, and Australia

• Lemtrada, new multiple sclerosis treatment, has potentially fatal side effects

Lemtrada, denied for use in the U.S. for treatment of multiple sclerosis, seeks appeal
Image at MS UK

Lemtrada, a drug used to treat multiple sclerosis, was rejected for use in the U.S. by the FDA.  Lemrtrada, generically known as alemtuzumab, was developed by France’s Sanofi, and is currently used in Europe, Canada, and Australia.  This decision sets Sanofi back on their hopes to gain more of a share of the $20 billion market for multiple sclerosis treatment.

The FDA stated that Sanofi’’s Lemtrada “did not submit evidence from adequate and well-controlled studies” proving that the benefits outweigh the side effects.  The FDA is concerned with some of the potential extreme side effects of Lemtrada.

Lemtrada was approved for treatment of multiple sclerosis by the European Union in September, and earlier this month in Canada and Australia.  In order to attempt further breakthrough to the U.S. market, the FDA indicated that further testing of Lemtrada against another drug are needed.

Some of the risks identified with taking Lemtrada include potentially fatal diseases like cancer, diabetes and autoimmune diseases.  It was also suspected that some of the participants in clinical trials for Lemtrada may have been aware of which drug they were receiving.

While the appeal for use of Lemtrada in the U.S. is underway, it is unknown how long this process may take.

Sanofi Genzyme President, David Meeker stated, “We are extremely disappointed with the outcome of the review and the implications for patients in the U.S. suffering with multiple sclerosis who remain in need of alternative therapies to manage a devastating disease.”

Multiple sclerosis is an inflammatory disease that affects the insulating covers of nerve cells in the brain and spinal cord.  The damage caused by multiple sclerosis can result in physical, mental, and in some cases psychiatric problems.  The cause of multiple sclerosis is currently unknown, but is suspected to be genetic, or potentially infection.