In a significant move, the European Medicines Agency (EMA) has recommended suspending the approval of Oxbryta, a medication developed by Pfizer for the treatment of sickle cell disease (SCD). This announcement follows Pfizer’s recent decision to voluntarily withdraw the drug from global markets, citing safety concerns.
Oxbryta was intended to treat SCD, a serious blood disorder predominantly affecting individuals of African, Middle Eastern, and South Asian descent. The EMA’s recommendation comes as a precautionary measure while it continues to assess new data regarding the drug’s safety profile.
According to the EMA, findings from two clinical studies indicated an increased incidence of “vaso-occlusive crises” among patients using Oxbryta. These crises can lead to severe pain and serious complications, including arthritis, kidney failure, and strokes. The agency has been reviewing the medication’s safety since July, prompted by alarming data suggesting a higher number of deaths associated with Oxbryta compared to placebo treatments.
The EMA’s statement emphasized that no new treatments with Oxbryta should be initiated, and healthcare professionals should advise existing patients to discontinue use. It also called for monitoring for adverse events once treatment has ceased.
Sickle cell disease is a group of inherited disorders characterized by the production of abnormal hemoglobin, which results in the deformation of red blood cells into a sickle shape. These misshapen cells can obstruct blood flow, leading to intense pain and life-threatening complications such as infections and acute chest syndrome.
In light of these developments, Pfizer stated it was “voluntarily withdrawing Oxbryta in all markets where it has been approved.” The pharmaceutical company acknowledged that, after reviewing the overall clinical data, it determined that the risks associated with Oxbryta no longer outweighed the potential benefits for patients suffering from sickle cell disease.
As the situation unfolds, the EMA and healthcare professionals remain committed to ensuring patient safety and managing the implications of this withdrawal for those affected by sickle cell disease.
