"Data from the open-label extension trial of Edaravone (Radicava) in patients with ALS demonstrated the drug continued to provide benefits after 48 weeks of treatment. These findings were presented by researchers from MT Pharma America, the company which manufactures Edaravone, at the May 18-20 European Network for the Cure of ALS (ENCALS) Annual Meeting.
'The 12-month data presented at ENCALS suggest early intervention with Radicava may lead to a meaningful clinical benefit when promptly initiated in people with ALS, as opposed to being delayed by six months,' Dr. Jean Hubble, vice-president for medical affairs at MT Pharma America, said in a press release.
The trial extension compared patients who had taken Radicava for 48 weeks to those treated with placebo for six months in the original Phase 3 trial, before switching to Radicava for another 24 weeks in the open-label study. Measurements of the ALS Functional Rating Scale-Revised (ALSFRS-R) showed that those who received Radicava for the full 48 weeks had significantly less physical decline and an about 58 percent lower relative risk of death or certain disease progression events."
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ALS Worldwide is in agreement with MT Pharma's findings, based upon observations and results from our edaravone compassionate usage with patients over the past year. Our supervision of these trials suggests the benefits of edaravone occur, to a somewhat but still very meaningful level, in patients of greater than one year duration of disease WHEN BEGINNING the protocol. Further, patient benefit continues AFTER a one-year period of using Edaravone. Results showed the positive impact of the drug to be greater after one year of use as opposed to near the beginning of the trial. The drug appears beneficial for an indefinite period of time.
FDA approved Edaravone for ALS on May 7. To learn more about the FDA approval, please visit:
We will continue to monitor and report all updates on Edaravone and its use for ALS patients, and we hope the results continue to show great promise and hope for all in the ALS community.