Oxbryta (Voxelotor) withdrawal from the UK market in the treatment of Sickle Cell Disorder in people aged 12 years and older

Pfizer Limited, in agreement with the Medicines Healthcare products Regulatory Agency (MHRA), has withdrawn the product, while a review of the benefits and risks is carried out. 

The withdrawal follows emerging clinical data from clinical trials and registry-based studies suggesting an unfavourable imbalance in the number of vaso-occlusive crises and fatal events in patients treated with voxelotor. 

Pfizer Limited, in a letter to healthcare professionals, has stated that: 

• New patients should not start treatment with Oxbryta. 
• Physicians should contact patients currently on treatment with Oxbryta to discontinue treatment, and where appropriate to discuss alternative treatment options with them. Physicians should instruct their patients to return the product to the hospital pharmacy or homecare company that dispensed it. 
• Physicians should continue to monitor patients for adverse events after their treatment with Oxbryta is discontinued and ensure appropriate follow-up as needed. 

As a result of the withdrawal, the MHRA has issued a Class 2 Medicines Recall. The recall asks that treatment teams stop supplying the above product immediately. Remaining stock should be quarantined and returned to the supplier using the supplier’s approved processes. 

Physicians, specialist prescribers, homecare company providers or any other healthcare professional responsible for prescribing voxelotor should contact all patients undergoing treatment and advise them to discontinue treatment and, where appropriate, discuss alternative treatment options.  

Patients should be instructed to return the product to the hospital pharmacy or homecare company that dispensed it. 

Further updates on the Marketing Authorisation of voxelotor will be provided by the MHRA in due course and any changes to NICE guidance will follow MHRA’s decision.