🇺🇸 SATRALIZUMAB in United States

FDA authorised SATRALIZUMAB on 14 August 2020 · 245 US adverse-event reports

Marketing authorisations

FDA — authorised 14 August 2020

  • Application: BLA761149
  • Marketing authorisation holder: GENENTECH
  • Local brand name: ENSPRYNG
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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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. Neuromyelitis Optica Spectrum Disorder — 58 reports (23.67%)
  2. Off Label Use — 43 reports (17.55%)
  3. Urinary Tract Infection — 28 reports (11.43%)
  4. Muscular Weakness — 21 reports (8.57%)
  5. Optic Neuritis — 18 reports (7.35%)
  6. Pneumonia — 18 reports (7.35%)
  7. Hypoaesthesia — 17 reports (6.94%)
  8. Fatigue — 15 reports (6.12%)
  9. Infection — 15 reports (6.12%)
  10. Myelitis — 12 reports (4.9%)

Source database →

SATRALIZUMAB in other countries

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

Frequently asked questions

Is SATRALIZUMAB approved in United States?

Yes. FDA authorised it on 14 August 2020; FDA has authorised it.

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

GENENTECH holds the US marketing authorisation.