USA — Pharmaceutical giant Pfizer has announced a voluntary withdrawal of all lots of OXBRYTA (voxelotor) from global markets.

OXBRYTA, an oral once-daily treatment approved for managing sickle cell disease (SCD), was designed to increase the oxygen affinity of haemoglobin, thereby reducing the polymerization of sickle haemoglobin.

The drug has been available in more than 35 countries worldwide.

Along with the product recall, Pfizer has decided to discontinue all active voxelotor clinical trials and global expanded access programs.

This decision follows comprehensive clinical data that suggests the risks associated with OXBRYTA may outweigh its benefits for patients with SCD.

Specifically, the data revealed an imbalance in vaso-occlusive crises and fatal events in patients treated with the drug, raising concerns that prompted further evaluation.

Following the release of these findings, Pfizer has promptly notified global regulatory authorities and initiated the voluntary withdrawal of OXBRYTA.

The company has also halted distribution of the drug and paused all ongoing clinical studies as it reviews the data and continues its investigation.

This process is deemed critical, as preventing sickling and the subsequent destruction of red blood cells is essential in managing haemolysis and haemolytic anaemia—two common and serious complications of SCD.

Pfizer’s Chief Medical Officer and Head of Worldwide Medical and Safety, Aida Habtezion, emphasized that patient safety is the company’s top priority.

She noted that while SCD remains a challenging disease with limited treatment options, Pfizer believes that discontinuing OXBRYTA is in the best interest of patients.

Habtezion advised patients currently using the medication to consult with their healthcare providers to explore alternative treatment options as Pfizer continues to investigate the safety concerns raised by the clinical data.

OXBRYTA initially received accelerated approval from the US Food and Drug Administration (FDA) in 2019 for treating SCD in patients aged 12 years and older.

The FDA later expanded the approval in December 2021 to include children as young as four. In Europe, OXBRYTA was granted PRIME (Priority Medicines) designation and orphan medicinal product status for treating SCD.

The European Commission granted marketing authorization for the drug in February 2022, allowing its use to treat haemolytic anaemia due to SCD in both adults and children aged 12 years and above, either as a monotherapy or in combination with hydroxyurea.

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