🇺🇸 Kesimpta in United States

FDA authorised Kesimpta on 26 October 2009 · 28,549 US adverse-event reports

Marketing authorisation

FDA — authorised 26 October 2009

  • Application: BLA125326
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: KESIMPTA
  • Indication: SOLUTION — SUBCUTANEOUS
  • Status: approved

Read official source →

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. Fatigue — 5,254 reports (18.4%)
  2. Headache — 4,429 reports (15.51%)
  3. Pain — 3,421 reports (11.98%)
  4. Chills — 3,364 reports (11.78%)
  5. Pyrexia — 3,231 reports (11.32%)
  6. Influenza Like Illness — 2,751 reports (9.64%)
  7. Nausea — 1,683 reports (5.9%)
  8. Multiple Sclerosis Relapse — 1,572 reports (5.51%)
  9. Covid-19 — 1,450 reports (5.08%)
  10. Asthenia — 1,394 reports (4.88%)

Source database →

Kesimpta 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 Kesimpta approved in United States?

Yes. FDA authorised it on 26 October 2009.

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

NOVARTIS holds the US marketing authorisation.