Data from the open-label extension trial of Radicava (edaravone; MT Pharma), the first new amyotrophic lateral sclerosis (ALS) treatment in over 20 years, showed that early intervention led to less decline in physical function for ALS patients.
The Food and Drug Administration’s (FDA) approval of Radicava was based on 6 month results from the MCI186-19 study, in which 137 ALS patients were randomized 1:1 to either Radicava or placebo. In the open-label extension phase, those who received placebo for the first 6 months began on Radicava, while the initial Radicava arm continued the treatment for another 6 months.
The group who received Radicava for the full 48 weeks had ALSFRS-R scores (a validated rating system for monitoring disability in patients with ALS) that continued to show statistically significant reductions for the rate of decline in physical function versus those who only began Radicava treatment after 6 months on placebo.
There was also an approximate 58% relative risk reduction in death or certain disease progression events in the 48-week Radicava group versus those given placebo initially.
“The 12-month data […] suggests that early intervention with Radicava may lead to a meaningful clinical benefit when promptly initiated in people with ALS,” said Jean Hubble, MD, VP Medical Affairs, MT Pharma America. “We strongly believe in the potential of Radicava to help people with this devastating disease, and are committed to continuing to advance clinical evidence for this treatment option.”
For more information call 844-772-4548 or visit Radicava.com.