Mitsubishi Tanabe Pharma America (MTPA) announced findings from an analysis of post-marketing safety data evaluating RADICAVA (edaravone) in a real-world setting during the first three years of availability in the United States (U.S.) for the treatment of amyotrophic lateral sclerosis (ALS).

RADICAVA maintained a similar safety profile as seen in clinical trials, with no new safety signals or inconsistencies with the clinical trials identified over the treatment period. Study findings were published in a paper entitled, "Analysis of the U.S. Safety Data for Edaravone (Radicava®) From the Third Year After Launch," in Drugs in R&D.

"We are pleased to share three-year findings from the post-marketing safety analysis of RADICAVA that reinforce its well-established safety profile as reported in clinical trials," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "We remain focused on learning as much as possible about the use of RADICAVA in a real-world setting, and these data signify an additional milestone toward achieving that goal."

RADICAVA was approved by the U.S. Food and Drug Administration (FDA) in May 2017, as an intravenous infusion treatment for ALS.

"I am encouraged to see that the safety and tolerability profile of RADICAVA observed over the three-year post-marketing treatment period is consistent with reports from the clinical trials," said Benjamin Rix Brooks, M.D., an ALS specialist and study author. "These data provide HCPs with additional insights they can share with patients when considering treatment with RADICAVA."