Pfizer Voluntarily Withdraws Sickle Cell Disease Treatment Oxbryta From Global Market Due To Painful Disease Complication, Deaths
Pfizer Voluntarily Withdraws Sickle Cell Disease Treatment Oxbryta From Global Market Due To Painful Disease Complication, Deaths
On Wednesday, Pfizer Inc. (NYSE:PFE) said the company 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.
辉瑞公司（NYSE:PFE）周三表示，公司目前自愿撤回在所有批次市场上批准使用的镰状细胞疾病（SCD）治疗药物Oxbryta（voxelotor）。
Pfizer is also discontinuing all active voxelotor clinical trials and expanded access programs worldwide.
辉瑞还将全球范围内停止所有活跃的voxelotor临床试验和扩大的获药计划。
Pfizer's decision is based on the totality of clinical data indicating that the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population.
辉瑞的决定基于临床数据的总体情况，表明Oxbryta的整体益处不再大于已批准的镰状细胞患者群体中的风险。
Also Read: FDA Battles Backlog of Drug Factory Inspections Since COVID-19.
另请阅读：FDA在COVID-19爆发后应对药品工厂检查积压问题。
The data suggest an imbalance in vaso-occlusive crises and fatal events that require further assessment.
数据表明在血管阻塞性危机和需要进一步评估的致命事件之间存在不平衡。
A vaso-occlusive crisis is a common painful complication of sickle cell anemia.
血管阻塞性危机是镰状细胞贫血常见的疼痛并发症。
Pfizer has notified regulatory authorities about these findings and its decision to voluntarily withdraw Oxbryta from the market and discontinue distribution and clinical studies while further reviewing the available data and investigating the findings.
辉瑞已通知监管机构有关这些发现，并就自愿撤回市场上的Oxbryta、停止分发和临床研究进行进一步审视可用数据并调查这些发现。
The company does not anticipate the event impacting its full-year 2024 financial guidance.
该公司预计此事件不会对其2024年全年财务指引产生影响。
In the second quarter of 2024, Oxbryta generated sales of $92 million, up 20% year-over-year. Pfizer added Oxbryta to its portfolio via its $5.4 billion buyout of Global Blood Therapeutics in 2022.
2024年第二季度，奥布利特销售额达到9200万美元，同比增长20%。辉瑞通过其在2022年以54亿美元收购全球血液疗法，将奥布利特纳入其组合。
In July, the European Medicines Agency (EMA) initiated a review of Oxbryta (voxelotor) following clinical trial data indicating a higher number of deaths in patients receiving Oxbryta compared to those on a placebo. Another trial also reported more deaths than expected overall.
7月，欧洲药品管理局（EMA）根据临床试验数据启动了对奥布利特（沃克索特）的审查，数据显示接受奥布利特治疗的患者死亡人数较安慰剂组多。另一项试验也报告了比预期更多的死亡案例。
One trial focused on patients with sickle cell disease who were at increased risk of stroke, while the other studied the drug's impact on leg ulcers, a common complication of the condition.
一项试验关注患有镰状细胞病且存在中风风险增加的患者，另一项研究了该药对腿部溃疡的影响，这是该控件的常见并发症。
The manufacturer has now halted Oxbryta treatment in both trials, which are pending further investigation.
制造商现已暂停了两项试验中奥布利特的治疗，正在等待进一步调查。
In November 2019, the FDA granted accelerated approval to voxelotor (Oxbryta) for adults and pediatric patients 12 years of age and older with sickle cell disease.
2019年11月，FDA加速批准了奥布利特（沃克索特）用于12岁及以上的成人和小儿患有镰状细胞病的患者。
Price Action: PFE stock is down 0.54% at $28.78 at the last check on Thursday.
股价表现：周四最后一次检查时，辉瑞股价下跌0.54%，报28.78美元。
- EXCLUSIVE: Vivani Medical Advances Its Obesity Treatment Implant With New Clinical Trial in Australia.
- 独家报道：Vivani医疗在澳洲展开新的临床试验，推进其肥胖症治疗植入物。
