Oxbryta (Voxelotor) Withdrawal
Published Updated
By People's Justice
What happened
The FDA broadens Oxbryta’s approval to include children aged 4 to 11, widening the population of sickle cell patients prescribed the drug.
Event date:
Source: fda.gov
Oxbryta (Voxelotor) Withdrawal
The FDA approves Oxbryta (voxelotor) under its accelerated-approval pathway for sickle cell patients aged 12 and older, based on the drug’s ability to raise hemoglobin levels — a surrogate endpoint rather than proof of fewer crises or deaths.
Source: fda.gov
Oxbryta (Voxelotor) Withdrawal
Pfizer voluntarily withdraws all lots of Oxbryta from markets worldwide and halts its voxelotor trials, citing clinical data showing an imbalance in vaso-occlusive crises and deaths. The FDA tells doctors to stop prescribing it.
Source: pfizer.com