On September 17, the European Commission, the European equivalent of the US Food and Drug Administration (FDA), approved the release of alemtuzumab (Lemtrada™.)
Alemtuzumab is an intravenous monoclonal antibody that selectively reduces circulating T lymphocytes, which are thought to be involved in inflammation in multiple sclerosis (MS). This reduction is followed by repopulation of T and B cells over time. It is administered on five consecutive days in the first year of therapy, followed by three consecutive days 12 months later.
Swedish Neuroscience Institute was involved in Care-MS II, one of the pivotal Phase III studies in which MS patients who had relapsed on other therapies were randomized to either alemtuzumab or interferon beta-1a. The drug was found to be significantly more effective in reducing annualized relapse rates (49.4% reduction compared to interferon beta-1a, and 54.9% compared to placebo in Care-MS I), and in slowing accumulation of disability (EDSS improved from baseline by 0.17 vs. interferon beta-1a with worsening of EDSS by 0.24.)
Side effects of the drug include infusion associated reactions, infections and low lymphocyte counts. Autoimmune reactions involving the thyroid gland, platelets and kidneys, were seen. As a result of the delayed onset of some of these autoimmune reactions, there will be a comprehensive risk management program to catch these side effects early.
The drug is pending FDA review, with a decision for release in the United States to be made by the end of 2013.