Latest News as of 01-02-2024
CRIZLANLIZUMAB
CRIZANLIZUMAB UPDATE
End of NHS supply – 01/02/2024
Adakveo (Crizanlizumab) stock has been recall following end of UK marketing authorisation
On January 10th 2024, the Crizanlizumab licence was withdraw by the Medicines and Healthcare products Regulatory Agency (MHRA). This meant that the NHS would have to end using it as a treatment for sickle cell disorder.
People who were already using Crizianlizumab before that decision are still able to continue using the treatment. However, stocks of Crizanlizumab in pharmacies are being recalled from 21st February 2024, therefore after this date Crizanlizumab will no longer be available to patients.
It is important that patients using Crizanlizumab speak to their consultant haematologist to discuss alternative treatments.”
CRIZANLIZUMAB UPDATE – 15/01/2024
We have been made aware by National Institute of Clinical Excellence (NICE) that the Medicines and Healthcare products Regulatory Agency (MHRA) has withdrawn the conditional marketing authorisation for crizanlizumab from Wednesday 10 January 2024 which had been a new and promising treatment for sickle cell disorder.
This means that from this date, no new patients will be prescribed Crizanlizumab, and those already on the drug need to discuss treatment options with their Consultant Haematologist.
We at The AOFAC Foundation are very disappointed by the decision made by the MHRA;
The news comes as a setback for both the patients who have been relying crizanlizumab since the introduction of the drug and the efforts to increase the quality of life for people affected by Sickle Cell Disorder.
AOFAC Foundation’s response to European Medicines Agency (EMA) and and Committee for Medicinal Products for Human Use (CHMP) updates on Crizanlizumab – 26/05/2023
This statement is an update to our previous statement on Crizanlizumab made on the 31/01/2023
As many of you will know, Crizanlizumab (Adakveo) was recommended as a new disease modifying treatment for sickle cell anaemia by National Institute of Clinical Excellence (NICE) and NHS England on a Managed Access Agreement. This means that the treatment was recommended to eligible patients under an agreement to collect more data about it.
Under the Managed Access Agreement, Crizanlizumab was recommended to eligible patients to collect more data about the treatment.
On the 26th May 2023, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) made a recommendation to revoke the conditional marketing authorization for crizanlizumab, a once-a-month, humanized anti-P-selectin monoclonal antibody infusion indicated for the prevention of recurrent vaso‑occlusive crises (pain crises) in sickle cell disease patients aged 16 years and older.
Findings from a recent study did not confirm that there was a clinical benefit of the drug in successfully reducing the number of painful crises requiring a healthcare visit or treatment at home in patients with sickle cell disease and so the benefits do not outweigh the risks.
“Whilst the recommendation of the European Medicines Agency has been made, the decision of the Medicines Healthcare products Regulatory Agency (MHRA) for England is still awaited.
We would like to reassure UK patients who are currently taking Crizanlizumab (Adakveo) as part of the Managed Access scheme, that it is safe.
However If you have any concerns, we recommend that you speak to your Consultant Haematologist who will determine the best option for each patient depending on their individual situation.
We will continue to provide more information when available.”