The US Food and Drug Administration has approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS).
Radicava is an intravenous infusion given by a healthcare professional. It is administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug-free.
The efficacy of edaravone for the treatment of ALS was demonstrated in a six-month clinical trial conducted in Japan. In the trial, 137 participants were randomised to receive edaravone or placebo. At week 24, individuals receiving edaravone declined less on a clinical assessment of daily functioning compared to those receiving a placebo.
According to an FDA release, the most common adverse reactions reported by clinical trial participants receiving edaravone were contusion and gait disturbance. Radicava is also associated with serious risks that require immediate medical care, such as hives, swelling, or shortness of breath, and allergic reactions to sodium bisulfite, an ingredient in the drug. Sodium bisulfite may cause anaphylactic symptoms that can be life-threatening in people with sulfite sensitivity.
The FDA granted this drug orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
The FDA granted approval of Radicava to Mitsubishi Tanabe Pharma America, Inc.