Pfizer withdraws Oxbryta from global markets, cites safety concerns
WEB17 hours ago · Pfizer has voluntarily withdrawn Oxbryta (voxelotor), a conditionally approved oral therapy for sickle cell disease (SCD), from worldwide markets, saying clinical data shows the treatment’s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 occurring in patients given Oxbryta in ...
MARAC Statement: Pfizer's Voxelotor (Oxbryta®) Withdrawal - Sickle Cell …
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 decision to withdrawal sickle cell drug leaves patients
WEB6 days ago · 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 scrambling for ways to...
FDA is alerting patients and health care professionals about the ...
WEB5 days ago · FDA approved Oxbryta under the accelerated approval pathway in 2019 for the treatment of sickle cell disease in adults and pediatric patients 12 years of age and older.
Sickle cell community scrambles after a Pfizer drug is pulled
WEB4 days ago · It had started last January, just shy of her 27th birthday, when she’d called to get a refill of a sickle cell drug called Oxbryta. There was some mix-up with her insurers; they wouldn’t pay...
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. The...
Pfizer Voluntarily Withdraws All Lots of Sickle Cell Disease …
WEB6 days ago · NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that it is voluntarily withdrawing all lots of OXBRYTA ® (voxelotor) for the treatment of sickle cell disease (SCD) at this time ...
Pfizer pulls sickle cell drug from market | Here & Now - WBUR
WEB16 hours ago · October 01, 2024. Doctors are struggling to figure out how to advise patients after Pfizer pulled a sickle cell drug from the market this week. The company recalled Oxbryta and ended clinical ...
Pfizer Voluntarily Withdraws All Lots of Sickle Cell Disease …
WEBPfizer Inc. (NYSE: PFE) announced today that it is voluntarily withdrawing all lots of OXBRYTA ® (voxelotor) for the treatment of sickle cell disease (SCD) at this time, in all markets where it is approved. Pfizer is also discontinuing all active voxelotor clinical trials and expanded access programs worldwide.
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...