FDA 擴大對 12 歲以上兒童慢性 HBV 的 Vemlidy 批准

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FDA 擴大對 12 歲以上兒童慢性 HBV 的 Vemlidy 批准
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FDA 更新了 25 mg 艾拉酚胺替諾福韋治療慢性乙型肝炎病毒伴代償性肝病的標籤適應症，將患者人群擴大到 12 歲以上的兒童。

Vemlidy（tenofovir alafenamide，Gilead Sciences）——一種核苷類似物逆轉錄酶抑製劑——之前在 2016 年被批准用於成年人群，當時它作為一種有效的治療方法超過了高劑量的 Viread（tenofovir disoproxil fumarate，Gilead Sciences）。
乙型肝炎細胞

“慢性乙型肝炎會對兒童的健康產生重大的長期健康影響，包括如果不及時治療，會在以後的生活中發展為肝癌，”聖地亞哥拉迪兒童醫院的兒科胃腸病學家 Kathleen Schwarz 醫學博士說。 在吉利德的新聞稿中。

資料來源：Adobe 股票

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FDA expands Vemlidy approval for chronic HBV in children aged older than 12 years
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The FDA has updated the label indication for 25 mg tenofovir alafenamide for the treatment of chronic hepatitis B virus with compensated liver disease, expanding the patient population to include children aged 12 years older.

Vemlidy (tenofovir alafenamide, Gilead Sciences) — a nucleoside analog reverse transcriptase inhibitor — was previously approved for the adult population in 2016, when it eclipsed the higher-dose Viread (tenofovir disoproxil fumarate, Gilead Sciences) as an effective treatment.
Hepatitis B cells

“Chronic hepatitis B can have a significant long-term health impact on children, including the development of liver cancer later in life if the disease is left untreated,” Kathleen Schwarz, MD, a pediatric gastroenterologist at Rady Children’s Hospital-San Diego, said in a Gilead press release.

Source: Adobe Stock