만성 B 형 간염 바이러스 감염 치료제

미국 식약청, Vemlidy 승인

Vemlidy는 Viread에 비해 신장과 뼈에 실험적 안전성이 향상되도록 유사한 효능이 검증된 1 일 1 회 치료제이다
Gilead Sciences, Inc. (Nasdaq : GILD)는 미국 식품 의약국 (FDA)이 만성 B 형 간염 바이러스 (HBV)에 감염된 간 질환 성인을위해 1 일 1 회 치료제인 Vemlidy® (테 노포 비어 알라 파 나이드, TAF) 25mg을 승인했다고 오늘 발표했다.

보도 자료에서 중요한 안전 정보는 아래를 참조하면 된다. 경고를 포함한 모든 처방 정보는 DOCUMENTS 탭에서 다운로드 할 수 있다.
연락처: Sung Lee, 투자자 - [phone]
Kelsey Grossman, 미디아 - [phone]

U.S. FOOD AND DRUG ADMINISTRATION APPROVES GILEAD’S VEMLIDY® (TENOFOVIR ALAFENAMIDE) FOR THE TREATMENT OF CHRONIC HEPATITIS B VIRUS INFECTION

-- Vemlidy is a Once-Daily Treatment that Demonstrated Similar Efficacy with Improved Renal and Bone Laboratory Safety Parameters Compared to Viread --

Foster City, Calif., November 10, 2016 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Vemlidy® (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.
Vemlidy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B. See below for important safety information.
Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 300mg. Data show that because Vemlidy has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to Viread, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. As a result, Vemlidy improved renal and bone laboratory safety parameters compared to Viread.
“Chronic hepatitis B is a life-threatening illness that affects up to 2.2 million people in the U.S.,” said Calvin Pan, MD, Clinical Professor of Medicine, NYU Langone Medical Center, and investigator in the Vemlidy clinical trials. “Clinical trials demonstrated Vemlidy is efficacious with improved renal and bone safety parameters compared to Viread, representing an important development for people living with this chronic disease.”
Photos and multimedia gallery available at www.GileadHBVMedia.com.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.