Takeda's Dengue Vaccine Candidate Under FDA Priority Review
Takeda's Dengue Vaccine Candidate Under FDA Priority Review
武田登革熱疫苗候選疫苗正在接受FDA的優先審查
- The FDA has accepted and granted priority review to Takeda Pharmaceutical Co Ltd's (NYSE:TAK) Biologics License Application (BLA) for TAK-003, the company's investigational dengue vaccine candidate.
- In the U.S., TAK-003 is being evaluated for the prevention of dengue disease caused by any dengue virus serotype in individuals four years through 60 years of age.
- Dengue is a mosquito-borne virus endemic in more than 125 countries.
- The TAK-003 application is supported by safety and efficacy data from the pivotal Phase 3 trial. The dengue vaccine candidate met its primary endpoint by preventing 80.2% of symptomatic dengue cases at 12 months.
- In addition, TAK-003 prevented 90.4% of hospitalizations at 18 months and, in an exploratory analysis, demonstrated protection against dengue fever through 4.5 years (54 months) after vaccination.
- Exploratory analyses showed that throughout the 4.5-year study follow-up, TAK-003 prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases in the overall population, including both seropositive and seronegative individuals.
- TAK-003 has not been approved by the FDA or any other health authority outside of Indonesia.
- In October 2022, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the approval of TAK-003.
- Price Action: TAK shares closed at $14.23 on Tuesday.
- FDA已接受並優先審查武田製藥株式會社(紐約證券交易所股票代碼：TAK)針對TAK-003的生物製品許可證申請(BLA)，TAK-003是該公司正在研究的登革熱候選疫苗。
- 在美國，TAK-003正在接受評估，用於預防由任何登革熱病毒血清型引起的4歲至60歲個體的登革熱疾病。
- 登革熱是一種蚊媒病毒，在125多個國家流行。
- TAK-003的應用得到了來自Pivotal階段3試驗的安全性和有效性數據的支持。登革熱候選疫苗在12個月時達到了主要終點，預防了80.2%的有症狀的登革熱病例。
- 此外，TAK-003在18個月時避免了90.4%的住院，並在一項探索性分析中顯示，在接種疫苗後4.5年(54個月)內對登革熱具有保護作用。
- 探索性分析表明，在整個4.5年的研究跟蹤期間，TAK-003預防了84%的住院登革熱病例和61%的有症狀的登革熱病例，包括血清陽性和血清陰性的個體。
- Tak-003尚未獲得FDA或印尼以外任何其他衞生當局的批准。
- 2022年10月，歐洲藥品管理局人用藥品委員會建議批准TAK-003。
- 價格行動：週二，德意志銀行的股價收於14.23美元。
譯文內容由第三人軟體翻譯。
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