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.
輝瑞公司（NYSE:PFE）週三表示，公司目前自願撤回在所有批次市場上批准使用的鐮狀細胞疾病（SCD）治療藥物Oxbryta（voxelotor）。
Pfizer is also discontinuing all active voxelotor clinical trials and expanded access programs worldwide.
輝瑞還將全球範圍內停止所有活躍的voxelotor臨床試驗和擴大的獲藥計劃。
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.
輝瑞的決定基於臨床數據的總體情況，表明Oxbryta的整體益處不再大於已批准的鐮狀細胞患者群體中的風險。
Also Read: FDA Battles Backlog of Drug Factory Inspections Since COVID-19.
另請閱讀：FDA在COVID-19爆發後應對藥品工廠檢查積壓問題。
The data suggest an imbalance in vaso-occlusive crises and fatal events that require further assessment.
數據表明在血管阻塞性危機和需要進一步評估的致命事件之間存在不平衡。
A vaso-occlusive crisis is a common painful complication of sickle cell anemia.
血管阻塞性危機是鐮狀細胞貧血常見的疼痛併發症。
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.
輝瑞已通知監管機構有關這些發現，並就自願撤回市場上的Oxbryta、停止分發和臨床研究進行進一步審視可用數據並調查這些發現。
The company does not anticipate the event impacting its full-year 2024 financial guidance.
該公司預計此事件不會對其2024年全年財務指引產生影響。
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，奧布利特銷售額達到9200萬美元，同比增長20%。輝瑞通過其在2022年以54億美元收購全球血液療法，將奧布利特納入其組合。
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，歐洲藥品管理局（EMA）根據臨床試驗數據啓動了對奧布利特（沃克索特）的審查，數據顯示接受奧布利特治療的患者死亡人數較安慰劑組多。另一項試驗也報告了比預期更多的死亡案例。
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.
一項試驗關注患有鐮狀細胞病且存在中風風險增加的患者，另一項研究了該藥對腿部潰瘍的影響，這是該控件的常見併發症。
The manufacturer has now halted Oxbryta treatment in both trials, which are pending further investigation.
製造商現已暫停了兩項試驗中奧布利特的治療，正在等待進一步調查。
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加速批准了奧布利特（沃克索特）用於12歲及以上的成人和小兒患有鐮狀細胞病的患者。
Price Action: PFE stock is down 0.54% at $28.78 at the last check on Thursday.
股價表現：週四最後一次檢查時，輝瑞股價下跌0.54%，報28.78美元。
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譯文內容由第三人軟體翻譯。