FDA Greenlights First New Treatment for ALS in More than Two Decades

Friday, May 05, 2017 | FDA Approval/Clearance , Multiple Sclerosis & Immune Disorders , Phase 3/4 Trials , Research and Publications


The FDA has approved Radicava (edaravone, MT Pharma), as an intravenous infusion treatment for amyotrophic lateral sclerosis (ALS). Radicava is the first treatment approved for the treatment of ALS in 22 years. The approval followed a 13-year comprehensive clinical development program, in which a pivotal Phase 3 study (MCI186-19) evaluating 137 people with ALS demonstrated that patients who received Radicava for six months experienced roughly 33 percent less decline in physical function than those receiving placebo.

The most common adverse reactions that occurred in more than 10 percent of patients and were bruising, gait disturbance, and headache.

Radicava is administered in 28-day cycles by intravenous infusion. It takes 60 minutes to receive each 60 mg dose, according to the company. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period.

The cost of Radicava per year is roughly $145,000. To bolster access to the drug, MT Pharma has created the Searchlight Support program, which offers personal case management, reimbursement support, and 24/7 clinical support to patients. 

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