
FDA Approves Lemtrada for the Treatment of Multiple Sclerosis
After being plagued by numerous delays, Lemtrada (alemtuzumab) has finally been approved by FDA for the treatment of multiple sclerosis.
Sanofi announced on Nov. 15, 2014 that FDA approved their drug Lemtrada (alemtuzumab) for the treatment of relapsing multiple sclerosis (MS). The approval follows a denial in December 2013, when FDA said through a
Rather than conduct new trials to satisfy FDA, Sanofi submitted enhanced efficacy data on their previously run CARE-MS I and CARE-MS II trials. In those trials, Lemtrada outperformed Rebif (interferon beta-1a). In both CARE-MS I and CARE-MS II trials, Lemtrada 12 mg was given intravenously a total of eight times over the course of the two-year study. In the CARE-MS I trial, the drug reduced the number of relapses by 78% and reduced the risk of disability by 71%, a number that Sanofi admitted was significant, but not statistically significant in terms of disease progression. In CARE-MS II, Lemtrada was "significantly more effective than interferon beta-1a at reducing annualized relapse rates and accumulation of disability was significantly slowed," according to a
Genzyme executives said Lemtrada will be priced at $158,000 for two courses of treatment over two years, compared with Rebif, which costs $134,600 for a similar regimen. A 2012
Genzyme also has another option to treat MS, oral medication Aubagio (teriflunomide). The approval of Lemtrada allows Genzyme to hold a bigger portion on the market in the treatment of MS. According to Genzyme President and CEO, David Meeker, the approval was “the culmination of more than a decade of work by Genzyme to develop Lemtrada.”
Because of the concern surrounding its safety, Lemtrada will come with a boxed warning, will only be recommended for patients who have had an inadequate response to two or more drugs indicated for the treatment of multiple sclerosis, and will only be available through a limited distribution model with a Risk Evaluation and Mitigation Strategy program.
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