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 Voluntarily Withdraws All Lots of Sickle Cell Disease …
WEB6 days ago · OXBRYTA should not be taken if the patient has had an allergic reaction to voxelotor or any of the ingredients in OXBRYTA. See the end of the patient leaflet for a list of the ingredients in OXBRYTA.
Pfizer withdraws Oxbryta from global markets, cites safety concerns
WEB9 hours ago · The second Phase 3 trial, called RESOLVE (NCT05561140), assessed Oxbryta’s impact on leg ulcers in 88 SCD patients, ages 12 and older.Eight deaths occurred in the open-label portion of the study. The Committee for Medicinal Products for Human Use, which had been reviewing data on Oxbryta following reports that some patients participating in studies had more VOCs during treatment than they ...
FDA is alerting patients and health care professionals about the ...
WEB5 days ago · Pfizer Inc., the manufacturer of Oxbryta, announced it is voluntarily withdrawing the medication from the market, ceasing distribution, and discontinuing all active clinical trials and expanded ...
Pfizer decision to withdrawal sickle cell drug leaves patients ...
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 ...
Pfizer pulls sickle cell pill Oxbryta over safety concerns - STAT
WEB6 days ago · Sept. 25, 2024. 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 ...
Pfizer withdraws sickle-cell disease treatment | Reuters
WEB6 days ago · Pfizer bought Oxbryta, also known as voxelotor, as part of its $5.4 billion buyout of Global Blood Therapeutics in 2022. It reported $328 million in revenues from the therapy for the full year 2023.
Pfizer pulls sickle cell disease therapy Oxbryta from markets
WEB6 days ago · Pfizer will voluntarily pull its sickle cell disease (SCD) drug Oxbryta from all markets worldwide, a major blow to a $5.4 billion acquisition the New York pharma made two years ago.
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 ...
FDA alerts patients about Pfizer's Oxbryta withdrawal
WEB5 days ago · Sept 26 (Reuters) - The U.S. Food and Drug Administration on Thursday alerted patients and healthcare professionals about the withdrawal of Pfizer's (PFE.N) sickle cell disease treatment Oxbryta ...