This suspension is a precautionary measure following reports of serious adverse reactions, pending full evaluation of the efficacy and safety data for this medicine. No further initiation of treatment is possible.
In France, all patients treated with Oxbryta have been contacted and informed or will be informed shortly. Their doctor will work with them to plan how to stop treatment and consider available therapeutic alternatives.
All batches of this medication still in stock in hospital pharmacies (PUI) will be recalled.
Oxbryta has had European Marketing Authorization since February 14, 2022 for the treatment of hemolytic anemia (by excessive destruction of red blood cells) in patients with sickle cell disease. In France, it is available via derogatory access (early post-MA access), as well as as part of a clinical trial.
Since the end of July 2024, Oxbryta has been the subject of a European re-evaluation of the benefit/risk balance of this medicine. Indeed, clinical trials carried out in several countries outside Europe have shown an increased risk of death during treatment with Oxbryta. Additionally, new data from the United States have demonstrated an increased frequency of vaso-occlusive crises in patients treated with Oxbryta.
In this context, the European Commission suspended the Marketing Authorization of Oxbryta on October 4, 2024, pending the conclusion of the CHMP re-evaluation.
A letter to the healthcare professionals concerned was sent by the Pfizer laboratory, holder of the Marketing Authorisation.
In consultation with the specialist doctors concerned and patient associations, the ANSM has developed procedures to follow.
View the letter to healthcare professionals
Procedures for patients
If you are currently being treated with Oxbryta, you have been or will be contacted by your doctor. He or she will see you for a consultation to assess how to stop your treatment, offer you a therapeutic alternative and consider appropriate monitoring.
Do not stop your treatment on your own. It cannot be ruled out that abruptly stopping Oxbryta could cause your disease to return. Be vigilant in situations that could lead to the onset of a crisis. At the first signs, consult your doctor or contact an emergency service: 15 (Samu), 18 (fire brigade) or 112 (all emergencies: medical, fire, security).
If you have any questions, contact your doctor.
Guidelines for prescribing doctors
No further treatment of a patient with Oxbryta can be initiated due to the suspension of Marketing Authorization.
If some of your patients are being treated with Oxbryta, contact them to explain how to stop their treatment, consider a therapeutic alternative as well as close therapeutic monitoring.
It cannot be ruled out that abrupt cessation of Oxbryta could lead to a rebound of the disease and increase the risk of vaso-occlusive crises (VOC): remind your patients of the main triggering factors. Encourage them to see you immediately or contact an emergency service if the first signs appear.
Conduct for PUI pharmacists
The marketing authorization for Oxbryta is suspended.
If you still have lots, they must be destroyed. The terms and conditions will be detailed to you by the laboratory.
Source: ANSM news from 10/10/2024
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