🇺🇸 LEQVIO in United States

FDA authorised LEQVIO on 22 December 2021 · 4,239 US adverse-event reports

Marketing authorisation

FDA — authorised 22 December 2021

  • Application: NDA214012
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: LEQVIO
  • 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. Arthralgia — 723 reports (17.06%)
  2. Myalgia — 541 reports (12.76%)
  3. Injection Site Pain — 501 reports (11.82%)
  4. Pain In Extremity — 419 reports (9.88%)
  5. Low Density Lipoprotein Increased — 415 reports (9.79%)
  6. Fatigue — 355 reports (8.37%)
  7. Pain — 355 reports (8.37%)
  8. Drug Ineffective — 335 reports (7.9%)
  9. Diarrhoea — 310 reports (7.31%)
  10. Dyspnoea — 285 reports (6.72%)

Source database →

LEQVIO in other countries

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

Other Cardiovascular approved in United States

Frequently asked questions

Is LEQVIO approved in United States?

Yes. FDA authorised it on 22 December 2021.

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

NOVARTIS holds the US marketing authorisation.