New Indications for Simponi Aria
October 20, 2017 – The U.S. FDA has approved new indications for Simponi Aria® (golimumab), manufactured by Janssen Pharmaceuticals, to treat active cases of psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in adult patients. Simponi Aria, a tumor necrosis factor (TNF) blocker, is delivered by intravenous infusion. The drug’s original indication is to treat rheumatoid arthritis (RA) when used in conjunction with methotrexate, and to prevent further joint damage due to RA.
Recommended dosing for Simponi Aria for the new indications is 50mg by subcutaneous injection once per month. Like other TNF blockers, Simponi Aria carries a black box warning to caution patients against the risk of severe infections, including tuberculosis, and the potential for development of lymphoma and other cancers in children and adolescents.
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.