MARAC Statement: Pfizer's Voxelotor (Oxbryta®) Withdrawal
WEB4 days ago · SCDAA Medical and Research Advisory Committee (MARAC) Statement: Pfizer’s Voxelotor (Oxbryta®) Withdrawal 9/27/24 What is the news? Pfizer announced the withdrawal of voxelotor (Oxbryta®) from national and global markets on September 25, 2024. Clinical research was also stopped. “Pfizer’s decision is based on the totality of clinical data that now indicate the overall benefit of […]
Pfizer withdraws Oxbryta from global markets, cites safety concerns
WEB11 hours ago · Pfizer has voluntarily withdrawn Oxbryta (voxelotor), a conditionally approved oral therapy for sickle cell disease (SCD), from worldwide markets, saying clinical data shows the treatment’s benefit “no longer outweighs the risk.”. Citing an imbalance in vaso-occlusive crises (VOCs) and deaths …
Pfizer decision to withdrawal sickle cell drug leaves patients ... - STAT
WEB6 days ago · Sept. 26, 2024. Pfizer’s decision Wednesday to pull its sickle cell pill off the market because of safety concerns shocked advocates and doctors, leaving many searching for answers and...
Sickle cell community scrambles after a Pfizer drug is pulled ... - STAT
WEB4 days ago · Nana-Bilkisu Habib experienced a health crisis earlier this year after missing doses of her sickle cell drug, Oxbryta. Courtesy Nana Habib. By Eric Boodman. Sept. 27, 2024. Eric Boodman, a...
Pfizer withdraws sickle cell treatment due to safety concerns
WEB5 days ago · Pfizer has voluntarily withdrawn its sickle cell disease treatment Oxbryta (voxelotor) from the market due to safety concerns. The Food and Drug Administration (FDA) recommends clinicians stop prescribing the treatment and patients talk to their doctor about starting a different treatment. “I am disappointed as many other providers, patients and families (are),” said Banu Aygun, M.D., FAAP ...
Pfizer Voluntarily Withdraws All Lots of Sickle Cell Disease …
WEB6 days ago · Risks and uncertainties include, among other things, uncertainties regarding the future of OXBRYTA (voxelotor), as well as uncertainties related to other sickle cell disease assets in our ...
Pfizer pulls sickle cell pill Oxbryta over safety concerns - STAT
WEB6 days ago · Pfizer said Wednesday that it was removing Oxbryta, a pill for the treatment of sickle cell disease, from all markets globally due to high risks of severe safety events, including deaths.
Pfizer Voluntarily Withdraws All Lots of Sickle Cell Disease …
WEBPfizer's decision is based on the totality of clinical data that now indicates the overall benefit of OXBRYTA no longer outweighs the risk in the approved sickle cell patient population. The data suggest an imbalance in vaso-occlusive crises and fatal events which require further assessment.
Pfizer withdraws sickle-cell disease treatment | Reuters
WEB6 days ago · Sept 26 (Reuters) - U.S. drugmaker Pfizer (PFE.N), opens new tab said on Wednesday it was withdrawing its sickle cell disease treatment Oxbryta from all markets where it is approved, citing risks ...
FDA approves novel treatment to target abnormality in sickle cell …
WEBToday, the U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of...