Oxbryta (voxelotor): Suspension of EU marketing authorisation.

Summary

• The marketing authorisation for Oxbryta is suspended in the European Union as a precautionary measure while the review of the benefits and risks of Oxbryta is ongoing. 
• All batches of Oxbryta are being recalled in the European Union.
• The use of Oxbryta in clinical trials and in early access programs is also being discontinued by the marketing authorisation holder.
• The suspension follows emerging clinical data from 2 registry-based studies suggesting an imbalance in the number of vaso-occlusive crises before and after initiation of the treatment with voxelotor, and fatal events on voxelotor in clinical trials.
• No new patients should start treatment with Oxbryta. 
• Physicians should contact patients currently on treatment with Oxbryta to discontinue treatment and discuss alternative treatment options with them.
• Physicians should continue to monitor patients for adverse events after their treatment with Oxbryta is discontinued and ensure appropriate follow-up as needed as possible complications when treatment is interrupted abruptly cannot be excluded, but neither efficacy nor a dose for gradual discontinuation have been established.

Published on: 07 October 2024