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Radicava
Published
Product name
Radicava
Active ingredient
Edaravone
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Radicava (edaravone) was approved for the following therapeutic use:
Radicava is indicated in adults with a diagnosis of amyotrophic lateral sclerosis who are independent in activities of daily living with normal respiratory function and where treatment is initiated within two years of disease onset.
Efficacy has not been demonstrated in patients outside of this defined population.
How this medicine works
The mechanism by which Radicava exerts its therapeutic effect in patients with amyotrophic lateral sclerosis (ALS) is unknown. Edaravone is a free radical scavenger to reduce oxidative stress.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Radicava was considered favourable for the therapeutic use approved.
Sponsor