FDA Expresses Concerns of New MS Drug
Reuters reports that officials with the U.S. Food and Drug Administration (FDA) have expressed concern with Sanofi’s new multiple sclerosis drug Lemtrada (alemtuzumab) following reports of “multiple serious and potentially fatal safety issues” recorded during clinical trials.
Concerns Over Lemtrada
- Multiple sclerosis (MS) is an autoimmune disease which attacks the central nervous system and affects approximately 2 million people worldwide.
- Though Lemtrada was granted marketing approval for the treatment of MS by the European Commission in September, but according to FDA staff, the adverse effects associated with the drug may be too serious to justify approval in the U.S.
- With the FDA expected to make its decision on rather or not to approve Lemtrada by the end of the year, it seems approval will be denied unless the drug demonstrates “substantial clinical benefit” that outweigh the risks of cancer, blood disorders and infection.
Side Effects of Lemtrada
According to DrugCite.com, adverse events linked to Lemtrada (alemtuzumab)include:
- Multi-organ Failure
- Renal Failure
- Suicidal Thoughts
- Respiratory Failure
- Hepatic Failure
- Cardiac Failure
- Weakened Immune System
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