The European Medicines Agency (EMA) has announced that the suspension of the marketing authorisation for Oxbryta, a medicine used to treat sickle cell disease, will remain in place.
Following a full review of new safety data, EMA’s human medicines committee (CHMP) concluded that the benefits of Oxbryta no longer outweigh its risks.
Recent clinical trials showed a higher number of deaths and more episodes of sudden severe pain (including VOC crises) among patients receiving Oxbryta compared with placebo. Although the reasons behind these complications remain unclear, the Committee determined that no effective risk-minimisation measures or patient subgroups could be identified to justify continued use of the medicine.
As a result, Oxbryta will remain unavailable for prescription within the European Union.
Read the official EMA communication here
 concludes that Oxbryta’s benefits no longer outweigh its risks, recommending that the medicine’s suspension remain in place across the EU.){kind=link}