Repatha (evolocumab)

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Repatha (evolocumab)

Repatha® has been studied in over 6000 patients in clinical trials.†4 Find out more about Repatha’s pivotal clinical trial data in three key patient groups:

Therapeutic indications7

Repatha® is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

  • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
  • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Repatha® is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.

The effect of Repatha® on cardiovascular morbidity and mortality has not yet been determined.

*Data from a randomised, double-blind, placebo- and ezetimibe-controlled, multicentre, international trial (LAPLACE-2) involving 1896 patients with primary hypercholesterolaemia or mixed dyslipidaemia.3 At the mean of Weeks 10 and 12, 86–95% of patients treated with either dose of Repatha® plus a statin (n=1117) achieved an LDL-C <70 mg/dl (<1.8 mmol/l).3 In patients receiving a statin alone (n=558), 2–39% of patients achieved an LDL-C <70 mg/dl (<1.8 mmol/l).3 In patients receiving atorvastatin plus ezetimibe (n=221) 17–62% of patients achieved an LDL-C <70 mg/dl (<1.8 mmol/l).3
In the LAPLACE-2, GAUSS-2, and RUTHERFORD-2 trials a total of 2532 patients were studied. Repatha® data presentations also include a pooled safety analysis in over 6000 patients from Phase 2 and 3 short- and long-term clinical trials.4
Included statin therapy with or without ezetimibe.
§Lipid-lowering therapy was used by 33%; 18% received a low-dose statin. Patients included in this study could not tolerate effective doses of at least two different statins due to muscle-related side effects.


LDL-C = Low-density lipoprotein cholesterol; PCSK9 = Proprotein convertase subtilisin/kexin type 9.

  1. Repatha®: EPAR - Public assessment report (www.ema.europa.eu).
  2. Stone NJ, et al. J Am Coll Cardiol. 2014;63(25 Pt 8):2889-934.
  3. Robinson JG, et al. JAMA 2014;311:1870-82.
  4. Toth PP, et al. J Am Coll Cardiol. 2015;65(10S):A1351.
  5. Raal FJ, et al. Lancet. 2015;385:331-40.
  6. Stroes E, et al. J Am Coll Cardiol. 2014;63:2541-8.
  7. Repatha® (evolocumab) Summary of Product Characteristics, July 2015.