News Feature | January 13, 2014

FDA Denies Approval Of MS Drug Lemtrada

Source: Clinical Leader

By Cassandra Leger

Genzyme was denied approval from the FDA for Lemtrada (Alemtuzumab), a drug used to treat multiple sclerosis. According to the statement made by Sanofi, the current owner of Genzyme, the FDA stated that the drug lacks the necessary amount of clinical trials needed to deem it a safe and effective treatment for MS. However, the drug has been approved in Europe since September 2013.

Lemtrada is commonly known as Campath-1H, which stands for Cambridge Pathology; the location of the discovery of its monoclonal antibodies as being viable for leukemia treatment. It wasn’t until 1990 when the drug was reconsidered and designated as a treatment for MS. In 2001, the drug was approved as a treatment for Chronic Lymphocytic Leukemia and researchers continued to use it as a treatment for MS and Rheumatoid Arthritis.

The clinical trials showed resulted in Alemtuzumab being able to prevent MS relapses, however when studied on individuals in their second stages of MS, the drug did not work as expected. It was determined that Alemtuzumab was only effective in patients in their early stages of MS and those who have not yet experienced nerve damage.

According to Dr. Alasdair Coles, an academic neurologist, the FDA was majorly concerned with the fact that both patients involved in the clinical trials and the doctors conducting them knew which test groups were reviving Lemtrada and which groups were taking placebos. Dr. Coles stated “The FDA has criticized the trials of Lemtrada for not attempting to blind the trial participants and physicians to their treatment and relying on a blinded rater to assess the effectiveness of Lemtrada. However, it is not possible to blind people to the immediate side-effects of Lemtrada, and all MS trials rely on a blinded rater. I remain confident in the results of these trials.”

The FDA stated that more clinical trials would be needed in order to determine if the drug really works. The drug does have serious health risks, including the reduction of white blood cells. During clinical trials, 30% of the patients taking Lemtrada developed secondary autoimmune diseases.