Radicava Approved to Treat Amyotrophic Lateral Sclerosis
May 5, 2017 – The U.S. FDA has approved the intravenous use of Radicava™ (edaravone injection) to treat patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. ALS gradually destroys nerve cells in the brain and spinal cord, depriving patients of the ability to move, speak, swallow and even breathe. Previously, the only FDA-approved drug for ALS was Rilutek® (riluzole – sanofi-aventis U.S.) tablets.
Each 60mg (two IV bag) Radicava dose will be given by a health provider as a 60-minute intravenous (IV) infusion. During the first 28-day dosing cycle, it will be administered once a day on the first 14 days, then not at all for the next 14 days. Subsequent cycles will include infusions of Radicava on 10 of the first 14 days, followed by 14 days without treatment. While the means by which Radicava functions is currently unknown, the treatment may shield nerves in the brain and spinal cord from damage.
Radicava’s manufacturer, MT Pharma America, a subsidiary of Mitsubishi Tanabe Pharma Corp., plans a U.S. launch in August. The estimated annual cost for Radicava is $145,500.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.