Friday, January 3, 2014
Alemtuzumab Is Not Ready for Approval, FDA Says
The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter this week to multiple sclerosis (MS) drug manufacturer Genzyme regarding alemtuzumab (Lemtrada). The letter, according to a press statement from Genzyme, states that “Genzyme has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects." The FDA also cited a need for differently designed active comparator clinical trials of alemtuzumab before approval.
Alemtuzumab is the first fully humanized monoclonal antibody, and works peripherally to disable circulating T and B cells, leading to profound and prolonged changes in the immune system. The MS medication has been the subject of rigorous debate due to its risk of serious side effects, including an array of autoimmune disease, along with the incidence of malignancies such as thyroid cancer and melanoma.
In a Nov. 14 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to discuss alemtuzumab, the FDA advisory committee voted (17 to 0, with one abstention) that the serious safety risks should not preclude the approval of the drug for use in certain MS patients — particularly those who had failed other therapies. However, two days before that meeting, the FDA released a briefing document compiled by three experts which called the relative benefit of the treatment into question when compared with substantial risks.
These votes “reflected the complexity of the questions at hand and probably reflected the FDA's confusion on the matter, and that is why they brought it to a committee,” explained Nathan B. Fountain, MD, professor of neurology and director of the F.E. Dreifuss Comprehensive Epilepsy Program at the University of Virginia School of Medicine, who chaired the FDA advisory committee. The full discussion: http://bit.ly/19PUkey.
See our previous coverage of the alemtuzumab debate here: http://bit.ly/19EYSKt.