12.12.2025 - European Commission final decision

With the publication of the European Commission's decision on 9 December 2025, the risk assessment procedure under Article 20 of Regulation (EC) No 726/2004 on Oxbryta (voxelotor) was concluded. 

The provisional suspension of the marketing authorisation ordered by the European Commission's decision of 4 October 2024 (C(2034)7069 (final)) thus becomes final. Therefore, the marketing authorisation for the medicinal product for human use Oxbryta (voxelotor) granted by Decision C(2022)989 (final) of 14 February 2022 is suspended on the basis of the scientific conclusions of this decision.

23.10.2025 - EMA confirms suspension of sickle cell disease medicine Oxbryta

Higher rate of death and disease complications in recent trials means benefit-risk balance no longer favourable

EMA’s human medicines committee (CHMP) has recommended that the marketing authorisation of the sickle cell disease medicine Oxbryta remain suspended. This recommendation follows interim measures taken by the Committee in September 2024, when it temporarily suspended the medicine to review emerging safety data.

19.12.2024 - Commission Implementing decision

Temporary Suspension of the marketing authorization for the medicinal product Oxbryta for sickle cell disease - precautionary measure during the review of new data

On September 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended that the marketing authorization for the medicine Oxbryta (voxelotor) for sickle cell disease be suspended. This measure was taken as a precautionary measure while a review of new data is underway.

Commission implementing decicion of 4.10.2024

27.09.2024 - Under evaluation

EMA’s human medicines committee (CHMP) has recommended suspending the marketing authorisation for the sickle cell disease medicine Oxbryta (voxelotor); this measure is taken as a precaution while a review of emerging data is ongoing.

31.07.2024 - Procedure started

EMA has started a review of Oxbryta (voxelotor) after data from a clinical trial showed that a higher number of deaths occurred with Oxbryta than with placebo (a dummy treatment) and another trial showed the total number of deaths was higher than anticipated.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Oxbryta - referral