The FDA has approved alemtuzumab (Lemtrada) as a treatment for patients with multiple sclerosis.
The FDA was careful to cite that use of alemtuzumab was a high-risk option since the drug may cause an increased risk for malignancies, including thyroid cancer, melanoma, lymphoproliferative disorders, neuropathy, which in some instances proved fatal.
The medication is also marketed as Campath, which was used as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). However serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia occured in patients receiving Campath. Effective September 4, 2012 it was no longer available commercially, but provided through the Campath Distribution Program free of charge.
A new study performed in the UK downplayed its severe side effects with a generally favorable conclusion of “Alemtuzumab is associated with disease stabilisation in the majority of patients with highly active RRMS over an average seven-year follow-up.”
Another paper published in 2012 claimed, “Through extended follow-up, alemtuzumab remained significantly more efficacious than IFNβ-1a, with a safety profile consistent with previous reports.”
After the FDA initially rejected the approval of alemtuzumab, lobbying by Genzyme finally succeeded in a reversal of the United States position because of its use in over 30 countries around the world including Canada, Australia, Scotland, Argentina, and the entire European Union. U.S. patients could easily go to another country for treatment.