Pfizer has announced the withdrawal of Oxbryta, a treatment for sickle cell disease, from global markets due to severe safety concerns, including potential fatalities.

Recent clinical data indicated that the risks associated with Oxbryta, such as increased vaso-occlusive crises and fatalities, outweigh its treatment benefits.

This decision comes just before a scheduled hearing by the European Medicines Agency (EMA) to review Oxbryta's safety, following observed mortality differences in clinical trials.

Concerns about Oxbryta's safety were first raised in July when the EMA highlighted deaths in two trials, leading to a recommendation for suspension of its authorization.

The company stated that the benefits of Oxbryta no longer outweigh the associated risks for patients, prompting the recall.

This withdrawal adds to Pfizer's challenges as it faces declining sales from COVID-related products and disappointing performances in other areas.

Oxbryta was initially approved by the FDA in 2019 and received marketing authorization from the European Commission in 2022, based on earlier studies showing hemoglobin improvements.

The withdrawal leaves most patients with mild-to-moderate symptoms reliant on hydroxyurea, a chemotherapy drug, for treatment.

The decision has left advocates and doctors shocked, as they scramble to inform patients about the withdrawal of the drug.

Wall Street analysts noted that Pfizer's withdrawal could prompt faster trials for rival treatments, such as mitapivat from Agios Pharmaceuticals.

Oxbryta generated $328 million in global sales in the previous year, but the current withdrawal highlights the evolving market landscape for sickle cell treatments.

Pfizer has informed regulators about the safety concerns and the recall of the drug, advising patients to consult their physicians for alternative treatments.