Cosentyx Approved with New Indications
January 15, 2016 – The U.S. Food and Drug Administration (FDA) approved Cosentyx (secukinumab) manufactured by Novartis’. New FDA approvals for Cosentyx include treatment for adults who have ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Cosentyx is an interleukin-17A (IL-17A) inhibitor originally approved to treat psoriasis in 2015. Recommended maintenance dosing for both of its new indications is 150mg every four weeks administered as a subcutaneous injection. New patients should be given 150mg loading doses once weekly for the first five weeks and then it can be decreased to once every four weeks. Clinical studies showed patients with either AS or PsA improved as compared with study participants who got placebo (inactive) injections. Cosentyx is distributed through a limited specialty network.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 a 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.