Label Update for Cosentyx
June 19, 2018 – The U.S. FDA has approved an update to the label for Cosentyx® (secukinumab), manufactured by Novartis. The manufacturer may now include data demonstrating the potential for Cosentyx to slow joint damage progression in patients with psoriatic arthritis.
In a clinical study, 88% of patients treated with Cosentyx 300mg experienced no worsening of structural joint damage after 24 weeks, compared to 74% of patients given a placebo. Psoriatic arthritis, which affects approximately two million people in the United States, can lead to irreversible joint damage and disability.
Cosentyx first received FDA approval in 2015. It holds indications to treat plaque psoriasis, ankylosing spondylitis, and psoriatic arthritis.
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.