February 7, 2018 / 7:30 PM / 6 months ago

BRIEF-Gilead Sciences Says FDA Approves Biktarvy For Treatment Of HIV-1 Infection

Feb 7 (Reuters) - Gilead Sciences Inc:

* U.S. FOOD AND DRUG ADMINISTRATION APPROVES GILEAD’S BIKTARVY® (BICTEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE) FOR TREATMENT OF HIV-1 INFECTION

* GILEAD SCIENCES INC - BIKTARVY HAS A BOXED WARNING IN ITS PRODUCT LABEL REGARDING RISK OF POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

* GILEAD SCIENCES - ‍ADDITIONAL CLINICAL TRIALS OF BIKTARVY ONGOING, INCLUDING A DEDICATED STUDY IN WOMEN; PLANS TO PRESENT DATA FROM STUDIES IN 2018​

* GILEAD SCIENCES - APPROVAL OF BIKTARVY SUPPORTED BY DATA FROM 4 ONGOING PHASE 3 STUDIES INCLUDING STUDIES 1489 & 1490 IN TREATMENT-NAÏVE HIV-1 INFECTED ADULTS

* GILEAD SCIENCES - APPROVAL OF BIKTARVY SUPPORTED BY DATA FROM 4 ONGOING PHASE 3 STUDIES INCLUDING STUDIES 1844 & 1878 IN VIROLOGICALLY SUPPRESSED ADULTS Source text for Eikon: Further company coverage:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below