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.
The recommendation follows emerging safety data from two registry-based studies, which indicate that patients in the studies had a higher occurrence of vaso-occlusive crises (VOC) during treatment with Oxbryta than they did before starting the medicine. Vaso-occlusive crises are among the most common complications of sickle cell disease; they involve episodes of acute pain and can lead to further health complications, such as arthritis, kidney failure and stroke…
