Actemra SC Receives New Indication to Treat Juvenile Arthritis
May 14, 2018 – The U.S. FDA has approved a new indication for Actemra® (tocilizumab) for subcutaneous (SC) injection, manufactured by Genentech, to treat patients at least two years of age who have active polyarticular juvenile idiopathic arthritis (PJIA). The drug can be used alone or in combination with methotrexate.
The decision is based on a clinical trial designed to determine appropriate dosing of Actemra SC for children with PJIA. The study also evaluated the safety of the drug in pediatric patients and found it to be comparable to Actemra IV for intravenous infusion.
Approximately 30% of children affected by juvenile idiopathic arthritis (JIA) in the United States are diagnosed with PJIA, which is one of six JIA subtypes. PJIA most often affects small joints in the body, including hands and feet, and can be found in the jaw and weight-bearing joints as well. Symptoms include redness and swelling in the affected joints.
Actemra was first approved in 2010 and is also indicated to treat rheumatoid arthritis, systemic juvenile idiopathic arthritis, giant cell arteritis, and CAR-T therapy induced severe or life-threatening cytokine release syndrome (CRS).
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 1-800-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.