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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.”