ADAKVEO® is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Reporting suspected adverse reactions after authorisation of ADAKVEO® is important to understand the safety profile of the treatment for sickle cell disease (SCD) patients.
Indication: ADAKVEO® (crizanlizumab) is indicated for the prevention of recurrent VOCs in patients with SCD who are aged 16 years and over. It can be given as an add-on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is inappropriate or inadequate1
ADAKVEO® has a conditional marketing authorisation and further evidence is awaited.
*The SUSTAIN study assessed the efficacy and safety of ADAKVEO® in patients between the ages of 16–65 years at 69 sites in three countries. The SUSTAIN study was a Phase II, double-blind, randomised trial where patients received 5 mg/kg ADAKVEO® (n=67); 2.5 mg/kg ADAKVEO® (n=66); or placebo (n=65), administered intravenously at week 0, 2, 6 and 4 weekly intervals thereafter over a period of 52-weeks.2
Key inclusion criteria:2
- 16 to 65 years of age
- Confirmed medical history or diagnosis of SCD (including HbSS, HbSC, HbSβ+-thalassaemia, HbSβ0-thalassaemia or other genotypes)
- With or without HU/HC
- Experienced 2–10 VOCs in the preceding 12 months
- Clinically acceptable medical history, physical examination, vital signs, clinical laboratory tests
Abbreviations: HC, hydroxycarbamide; HU, hydroxyurea; SCD, sickle cell disease; VOCs, vaso-occlusive crises.
- ADAKVEO® Summary of Product Characteristics.
- Ataga KI, et al. N Engl J Med. 2017;376(5):429–439.