FDA Approves Genzyme Corporation’s Lemtrada For MS
Published: Nov 17, 2014
November 17, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Genzyme announced Friday that the U.S. Food and Drug Administration (FDA) approved the company’s multiple sclerosis (MS) drug Lemtrada, also known as alemtuzumab. Because of the drug’s potential serious side effects, the company said it should be reserved for patients who have already tried at least two other treatments which have already failed.
Boston-based Genzyme, a Sanofi company, has focused on MS research for years. Lemtrada is its second MS drug approved in the past two years. The first, approved in 2012, is a once-daily, oral treatment named Aubagio, also known as teriflunomide.
“[Friday’s] approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” Genzyme’s President and CEO, David Meeker, was quoted as saying in the company’s press release. He further explained that, “Lemtrada demonstrated superior efficacy over [Serono and Pfizer Inc. ’s MS drug] Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy (REMS) will be instituted in order to help detect and manage the serious risks identified with treatment.”
According to Genzyme, side effects of Lemtrada include a risk of serious, sometimes fatal autoimmune conditions, a risk of serious and life-threatening infusion reactions and an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders.
The Risk Evaluation and Mitigation Strategy (REMS) for Lemtrada means only certified prescribers, healthcare facilities and specialty pharmacies would have access to the drug. In addition, patients must enroll in the REMS program, which is intended to provide up-to-date information to patients and healthcare providers alike on the serious risks of Lemtrada. The program will also provide information about the appropriate monitoring required for detection of risks for up to 48 months after the last infusion of the drug. According to the company’s press release, the REMS program is based on a similar, successfully implemented plan run during the Phase 2 and 3 trials that helped detect and manage the risks of Lemtrada.
According to the National Multiple Sclerosis (MS) Society, more than 2.3 million people globally suffer from MS. “The FDA approval of Lemtrada is a significant milestone for people living with relapsing MS in the United States,” Timothy Coetzee, chief of advocacy, and a services and research officer at the National MS Society, was quoted as saying in the press release. “We are pleased that the voices of the MS community have been recognized and that people with relapsing MS will now have access to a new, needed treatment option,” he continued.
Lemtrada has been approved for use in more than 40 countries, including those of the European Union, where it was approved in Sept. 2013.