GSK Seeks FDA Approval For Oral Antibiotic For Urinary Tract Infections, Probably First In New Class In Over 20 Years
GSK Seeks FDA Approval For Oral Antibiotic For Urinary Tract Infections, Probably First In New Class In Over 20 Years
Over half of all women are affected by uUTIs in their lifetime, with approximately 30% suffering from recurrent disease.On Wednesday, the FDA accepted GSK plc's (NYSE:GSK) marketing application seeking approval for gepotidacin, an investigational, oral antibiotic for adult and adolescent females with uncomplicated urinary tract infections (uUTIs).
週三，美國食品藥品管理局接受了葛蘭素公司（紐約證券交易所代碼：GSK）的上市申請，該申請要求批准gepotidacin。gepotidacin是一種用於無併發症尿路感染（UUTI）的成年和青少年女性的研究性口服抗生素。
The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act (PDUFA) action date of March 26, 2025.
美國食品和藥物管理局已批准對該申請進行優先審查，並將《處方藥使用者費用法》（PDUFA）的生效日期定爲2025年3月26日。
Also Read: GSK Sues Moderna Alleging mRNA Vaccine Patent Infringement.
另請閱讀：葛蘭素史克起訴莫德納，指控其侵權 mRNA 疫苗專利。
Over half of all women are affected by uUTIs in their lifetime, with approximately 30% suffering from recurrent disease.
超過一半的女性在一生中都受到尿路感染的影響，大約30％的人患有複發性疾病。
New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing and can result in higher treatment failure rates.
由於耐藥細菌引起的UUTI數量不斷增加，可能導致更高的治療失敗率，因此需要新的治療方法。
Gepotidacin is a late-stage antibiotic in GSK's growing infectious disease portfolio and could be the first in a new class of oral antibiotics for uUTIs in over 20 years.
Gepotidacin是葛蘭素史克不斷增長的傳染病產品組合中的一種晚期抗生素，可能成爲20多年來針對UUTI的新一類口服抗生素中的第一種。
The application is supported by data from phase 3 EAGLE-2 and EAGLE-3 trials.
該應用程序由第 3 階段 EAGLE-2 和 EAGLE-3 試驗的數據支持。
In these studies, gepotidacin demonstrated non-inferiority to nitrofurantoin, the current standard of care for uUTI with a confirmed uUTI and a uropathogen susceptible to nitrofurantoin.
在這些研究中，gepotidacin表現出不遜色於呋喃妥因，硝基呋喃妥因是目前的尿道感染治療標準，已確診的尿路感染和一種易受硝基呋喃妥因的尿路病原體。
In EAGLE-3, gepotidacin achieved statistically significant superiority versus nitrofurantoin, demonstrating therapeutic success in 58.5% of participants compared to 43.6% for nitrofurantoin.
在 EAGLE-3 中，吉波替達辛與呋喃妥因相比取得了統計學上的顯著優勢，58.5% 的參與者顯示出治療成功，而呋喃妥因的治療成功率爲 43.6%。
In EAGLE-2, gepotidacin demonstrated therapeutic success in 50.6% of participants compared to 47.0% for nitrofurantoin.
在 EAGLE-2 中，gepotidacin在50.6％的參與者中顯示出治療成功，而硝基呋喃妥因的這一比例爲47.0％。
The development of gepotidacin has been partially funded by federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA).
gepotidacin的開發部分由美國衛生與公共服務部、戰略準備和反應管理局、生物醫學高級研究與發展管理局（BARDA）的聯邦資金資助。
Price Action: GSK stock is up 0.40% at $39.12 at last check Wednesday.
價格走勢：週三最後一次檢查時，葛蘭素史克股價上漲0.40％，至39.12美元。
Image via Shutterstock
圖片來自 Shutterstock
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譯文內容由第三人軟體翻譯。
