Pfizer has voluntarily withdrawn OXBRYTA (voxelotor) from all markets due to an imbalance in vaso-occlusive crises and fatal events observed in clinical data. The company is also discontinuing clinical trials and expanded access programs for the drug worldwide.
According to Pfizer, the overall benefit of OXBRYTA no longer outweighs the risk in the approved patient population with sickle cell disease (SCD). The data suggests increased incidences of serious events, prompting the company’s decision to withdraw the drug while further investigating the findings.
Pfizer’s Chief Medical Officer, Aida Habtezion, emphasized the importance of patient safety, stating that the action was taken in the best interests of patients. Habtezion acknowledged the challenges of treating SCD and the limited treatment options available.
Pfizer has notified regulatory authorities and advised patients to consult with their physicians for alternative treatments. Patients and healthcare professionals with questions about OXBRYTA can contact Pfizer Medical Information at 1-800-438-1985.
The withdrawal of OXBRYTA underscores the ongoing challenges in treating SCD, a debilitating and life-threatening blood disorder that affects millions worldwide. It also highlights the importance of ongoing research and the need for safer and more effective therapies.
SCD is an inherited disorder that causes sickle-shaped red blood cells, leading to inflammation, anemia, and organ damage. It is a chronic and potentially life-threatening condition that manifests in childhood and can significantly shorten life expectancy.
OXBRYTA was approved in 2019 for the treatment of SCD. It worked by increasing hemoglobin’s affinity for oxygen, thus inhibiting red blood cell sickling and destruction.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
