1. Medicines
  2. Haematology
  3. ADAKVEO® ▼ (crizanlizumab)
  4. The impact of VOCs
  5. Unmet needs

Prescribing information

 

There are still unmet needs for patients with sickle cell disease (SCD)

Patients may still experience VOCs despite hydroxyurea/hydroxycarbamide (HU/HC) treatment1

 

Under title: There are still unmet needs for patients with sickle cell disease (SCD)- Red circular image with '62% n=82/132' written on it. Image represents 62% of SCD patients were on a stable dose of HU/HC baseline.

There is a large unmet need for many patients with SCD, as 62% (n=123/198) of patients with SCD who were on a stable dose of HU/HC at baseline experienced 2–10 VOCs in the 12 months prior to enrolment in the SUSTAIN* study1

 

HU/HC is also not indicated for patients with HbSC, the second most common SCD genotype2

 

Banner title: Current treatment options do not address the needs of all patients with SCD.

 

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 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 inadequate.3

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.1

Key inclusion criteria:1

  • 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: HbSC, SCD genotype; HC, hydroxycarbamide; HU, hydroxyurea; SCD, sickle cell disease; VOCs, vaso-occlusive crises.

References

  1. Ataga KI, et al. N Engl J Med. 2017;376(5):429–439.
  2. Luchtman-Jones L, et al. Am J Hematol. 2016;91(2):238–242.
  3. ADAKVEO® Summary of Product Characteristics.
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UK | May 2021 | 104642
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ADAKVEO® has a conditional marketing authorisation and further evidence is awaited.

For more information, refer to the ADAKVEO® ▼ (crizanlizumab) prescribing information available here:  https://www.health.novartis.co.uk/sites/health.novartis.co.uk/files/adak...

Legal Category: POM.

Marketing Authorisation (MA) number, quantities and price: EU/1/20/1476/001  £1,038.00 per 10ml vial

 

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]