Prescribing information

 

ADAKVEO® reduces time in hospital1,2

 

A key secondary endpoint in the SUSTAIN study reviewed the annual rate of days a patient was hospitalised, including those related to VOCs in ADAKVEO® patients vs. placebo.2 In this analysis, a 42% reduction in the median annual rate of days hospitalised was seen in patients treated with ADAKVEO® vs. placebo:1,2

 

A bar graph showing ADAKVEO® reduces time in hospital: 42% reduction for ADAKVEO® n=67.

 

In a post-hoc analysis of the SUSTAIN study, patients treated with ADAKVEO® saw a ~39% reduction in the annual rate of hospitalisations per patient compared with placebo (1.00 vs. 1.63; ARR 0.63; HL 0.00, 95% CI, -1.00, 0.00)1†

 

Image a magnifying glass next to a red banner title: Access the SUSTAIN study.

 

Banner title: Patients treated with ADAKVEO spent less time in hospital vs. placebo.

 

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.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: ARR, absolute risk ratio; CI, confidence interval; HC, hydroxycarbamide; HL, Hodges Lehmann; HU, hydroxyurea; SCD, sickle cell disease; VOC, vaso-occlusive crisis.

References

  1. Ataga KI, et al. Crizanlizumab Treatment Is Associated With Clinically Significant Reductions in Hospitalization in Patients With Sickle Cell Disease: Results From the SUSTAIN study Poster presented at the 61st ASH Annual Meeting & Exposition, Orlando, FL, USA, December 7–10, 2019.
  2. Ataga KI, et al. N Engl J Med. 2017;376(5):429–439.
  3. ADAKVEO® Summary of Product Characteristics.

 

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UK | May 2021 | 104651
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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]