Pfizer withdraws sickle cell disease treatment on risk of …
WEB3 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 is alerting patients and health care professionals about the ...
WEB2 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 to pull sickle cell drug from market, shut down trials
WEB3 days ago · Dive Brief: Pfizer is pulling the sickle cell disease drug Oxbryta off the market and ending clinical trials of the medicine around the world due to safety concerns. Clinical data “now indicates that the overall benefit of Oxbryta no longer outweighs the risk,” Pfizer said Wednesday. The company said data show an imbalance of deaths and ...
FDA is Alerting Patients and Health Care Professionals About the ...
WEB3 days ago · In 2021, FDA granted accelerated approval of Oxbryta for the treatment of sickle cell disease in patients 4 to 11 years of age. Accelerated approval is based on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit, allowing for earlier approval of drugs that treat serious conditions and fill an ...
Pfizer pulls sickle cell disease therapy Oxbryta from markets
WEB3 days ago · Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to a $5.4 billion acquisition the New York pharma made two years ago. Pfizer will stop ...
Pfizer to Withdraw Sickle Cell Drug Oxbryta Lots from World …
WEBPfizer had tried to develop its own sickle cell drug, but it failed. In 2019, Global Blood Therapeutics won approval in the U.S. for Oxbryta. Sickle cell is an inherited blood disorder that ...
Pfizer Withdraws SCD Drug Oxbryta after EMA Discloses 16 …
WEB3 days ago · Pfizer inherited Oxbryta when it acquired the drug’s original developer, Global Blood Therapeutics (GBT), for $5.4 billion, a deal completed in October 2022. At the time, Pfizer said the deal ...
Pfizer Voluntarily Withdraws All Lots of Sickle Cell Disease …
WEB4 days ago · 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, in all markets where it is approved. Pfizer is also discontinuing all active voxelotor clinical trials and expanded access programs worldwide. Pfizer's decision is based on the totality of …
Pfizer's Oxbryta exit may hasten trials of rival experimental sickle ...
WEB2 days ago · Pfizer's shares were marginally down on Thursday. The stock is trading at around half its pandemic highs. Oxbryta was the centerpiece of Pfizer's $5.4 billion buyout of Global Blood Therapeutics ...
EMA recommends suspension of sickle cell disease medicine Oxbryta
WEB3 days ago · EMA’s human medicines committee (CHMP) has recommended suspending the marketing authorisation for the sickle cell disease medicine Oxbryta (voxelotor); this measure is taken as a precaution while a review of emerging data is ongoing. The recommendation follows emerging safety data from two registry-based studies, which …
Skip to content