The doctors who participated in clinical trials of Lemtrada, a multiple sclerosis (MS) drug, are protesting the Food and Drug Administration’s (FDA) decision to reject the medication. Alasdair J. Coles and Alastair Compston, along with a group of physicians, wrote a letter to the journal The Lancet to “urge the FDA to re-evaluate and revoke this decision.” Lemtrada (alemtuzumab) is approved in Canada, Europe, Mexico, Australia, and Genzyme recently announced in a press release, that the drug has been approved in Brazil.
Genzyme Corporation, a Sanofi Company, expressed displeasure with the FDA’s rejection in December of 2013. Genzyme President and CEO, David Meeker, M.D. said, “We strongly believe that the clinical development program, which was designed to demonstrate how Lemtrada compares against an active comparator as opposed to placebo, provides robust evidence of efficacy and a favorable benefit-risk profile. This evidence was also the basis for the approvals of Lemtrada by other regulatory agencies around the world.”
MS is a central nervous system (CNS) disorder wherein the immune system directs an abnormal response against the spinal cord, brain, and optic nerves. The immune system targets the myelin, nerve fiber insulation, and the nerves, forming scars or sclerosis. Damaged myelin and nerves cause mild, moderate, or severe disruptions in nerve pathways, causing a broad range of symptoms and disabilities, including difficulty speaking and walking.
Complete Response Letter
Genzyme received a Complete Response Letter, which is official communication from the federal agency regarding a drug application. Genzyme, in a press release, informed the public of the FDA’s position on rejecting the drug. The FDA said that clinical trials were not adequate or well controlled. The agency requested more clinical trials with a different design.
The group of physicians that wrote the letter in The Lancet participated in some way in the development of the drug. The doctors wrote that they have been involved with alemtuzumab since 1991. They said that they had “complete confidence” in the results that were published in major journals. They also pointed out that other drugs have been approved with the same trial design, and that trials without a placebo are often the only option, especially with MS drugs. The doctors conclude that the drug is available in other countries and that the FDA is leaving Americans with unmet therapeutic needs. They urge the FDA to reconsider.