Lemtrada Approved for Multiple Sclerosis
November 15, 2014 – Genzyme, a Sanofi company, received approval from the U.S. Food and Drug Administration (FDA) for Lemtrada™ (alemtuzumab), used in treating patients with relapsing forms of multiple sclerosis (MS) who have had an inadequate response to two or more MS therapies. Lemtrada’s recommended dose is 12mg/day administered as a four-hour intravenous (IV) infusion on five consecutive days. One year after the first treatment, 12mg/day on three consecutive days is recommended.
Sanofi plans on launching Lemtrada the first week of December. Lemtrada is only available through a restricted distribution program, Lemtrada Risk Evaluation and Mitigation Strategy (REMS), which has been developed to ensure that access to Lemtrada in the U.S. is only through certified prescribers, healthcare facilities and specialty pharmacies.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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