FDA Has Concerns About New Multiple Sclerosis Drug Amaya

Food and Drug Administration officials say an experimental drug designed to help people with the degenerative disease multiple sclerosis (MS) walk better may have only limited benefits.

Acorda Therapeutics Inc. wants the FDA to approve Amaya solely for use in treating a common symptom of the disease. The drug is not a cure or treatment for MS, which also causes muscle weakness, difficulty balancing, and paralysis in the most serious cases.

While Acorda claims two internal studies found that Amaya “provides rapid, significant, and clinically relevant improvements in walking ability,” some FDA staffers are not convinced.

In memos released today in advance of an FDA advisory panel meeting next week, officials said Amaya appears to have only “a very limited effect,” according to a Reuters news report.

FDA Staffers Question Amaya Effects

Acorda said one of its study included about 300 patients and found that 35 percent of the 224 patients treated with Amaya saw an improvement in their walking speed compared to patients given inactive placebo pills. Amaya patients improved their walking speed by on average eight percent more than the placebo study participants, the company said.

FDA staff said looking more closely at the company study found that the length of time it took patients taking Amaya to walk 25 feet was no different than for those given a placebo.

“For these reasons, it appears that the clinical meaning of the differences seen … is in question,” FDA staff said in their review, according to Reuters.

Seizure Risk Also Noted

There also are concerns about whether Amaya, which contains the drug fampridine, might cause seizures. The FDA may ask the advisory panel to determine whether the proposed 10-milligram dose of Amaya should be lowered to address the concerns about seizures.

The FDA is not required to follow the recommendations of its advisory expert panels, but in most cases, it does so.

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