FDA Approves Mitsubishi Tanabe Oral Form of Radicava for ALS

The FDA approved Mitsubishi Tanabe Pharma’s oral version of Radicava (edavarone) for patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease.

The agency previously approved the drug in an injectable formulation on May 5, 2017, for treatment of the rare progressive neurodegenerative disease.

The new approval was supported by a study in 137 participants who received either Radicava or placebo. By week 24, participants taking Radicava showed less decline in daily functioning compared with the placebo group. In a separate study, the oral dosage was shown to be present at comparable levels in the bloodstream compared with the injectable version.

The FDA recommended a 105 mg/5 mL dose of Radicava in an oral suspension or through a feeding tube.