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New Amyotrophic Lateral Sclerosis Drug Approved By FDA

July 25, 2017

Radicava (edaravone), the first new drug to treat amyotrophic lateral sclerosis (ALS), has been approved by the US Food and Drug Administration. The drug is taken intravenously daily for 14 says, followed by 14 days without the drug. The excitement stems both from Radicava’s potential to treat the disease and the hope that its approval will lead to future treatment authorizations.

The FDA's approval of Radicava was based on a 6-month clinical trial in Japan that included 137 patients who received either the drug or an inactive placebo, the agency said. After 24 weeks, patients taking the drug had less decline in physical functioning than those taking the placebo. The most common side effects among patients taking the drug were bruising and gait disturbance.

When this new drug arrives in August, it will come with al sit price of nearly $1,100 per infusion, meaning a year’s worth of treatment will be around $146,000. But as an approved drug, Radicava is eligible for private insurance coverage. Government aid also exists, and MT Pharma is working with insurance carriers and pharmacies to come up with a final price. The company is also running a patient assistance program, Searchlight Support, which includes medical helplines, infusion center locations, and ways of addressing cost.

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