FDA Rejects MS Drug Lemtrada
FDA Rejects MS Drug Lemtrada
Dec. 30, 2013 -- The FDA has rejected the new multiple sclerosis drug Lemtrada, saying the drugmaker didn’t show the drug's benefits outweigh some serious risks.
The agency asked the maker, Genzyme, to test the drug in more clinical trials.
The drug was to be used for relapsing-remitting MS, the most common type.
MS affects about 400,000 people in the U.S. Blurred vision, balance problems, slurred speech, and memory problems of MS can be disabling.
Genzyme says in a news release it plans to appeal the FDA’s decision on Lemtrada (alemtuzumab).
The drug has been approved in Canada, the European Union, and Australia. In the U.S. it received a mixed review from an FDA advisory committee in November. At that time, several members raised concerns about its safety.
The FDA had earlier approved the drug to treat leukemia, marketed as Campath.
Lemtrada is given as an infusion. It was expected to be used in MS patients who did not respond to other treatments.
Signs of Multiple Sclerosis Relapse
The agency asked the maker, Genzyme, to test the drug in more clinical trials.
The drug was to be used for relapsing-remitting MS, the most common type.
MS affects about 400,000 people in the U.S. Blurred vision, balance problems, slurred speech, and memory problems of MS can be disabling.
Genzyme says in a news release it plans to appeal the FDA’s decision on Lemtrada (alemtuzumab).
The drug has been approved in Canada, the European Union, and Australia. In the U.S. it received a mixed review from an FDA advisory committee in November. At that time, several members raised concerns about its safety.
The FDA had earlier approved the drug to treat leukemia, marketed as Campath.
Lemtrada is given as an infusion. It was expected to be used in MS patients who did not respond to other treatments.
Signs of Multiple Sclerosis Relapse
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