🇺🇸 Cosentyx in United States

FDA authorised Cosentyx on 21 January 2015 · 132,062 US adverse-event reports

Marketing authorisations

FDA — authorised 21 January 2015

  • Application: BLA125504
  • Marketing authorisation holder: NOVARTIS PHARMS CORP
  • Status: supplemented

FDA — authorised 6 October 2023

  • Application: BLA761349
  • Marketing authorisation holder: NOVARTIS PHARMS CORP
  • Status: supplemented

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Drug Ineffective — 27,708 reports (20.98%)
  2. Psoriasis — 22,028 reports (16.68%)
  3. Pain — 15,559 reports (11.78%)
  4. Arthralgia — 13,949 reports (10.56%)
  5. Fatigue — 9,743 reports (7.38%)
  6. Psoriatic Arthropathy — 9,266 reports (7.02%)
  7. Pruritus — 8,903 reports (6.74%)
  8. Malaise — 8,778 reports (6.65%)
  9. Rash — 8,342 reports (6.32%)
  10. Condition Aggravated — 7,786 reports (5.9%)

Source database →

Cosentyx in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Immunology approved in United States

Frequently asked questions

Is Cosentyx approved in United States?

Yes. FDA authorised it on 21 January 2015; FDA authorised it on 6 October 2023; FDA has authorised it.

Who is the marketing authorisation holder for Cosentyx in United States?

NOVARTIS PHARMS CORP holds the US marketing authorisation.