Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and a Type II variation to the European Medicines Agency (EMEA) for marketing approval of Viread® (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B in adults. Viread is already approved in the United States and European Union for the treatment of HIV as part of combination antiretroviral therapy. "New treatments are critically important in the fight against chronic hepatitis B, a potentially life-threatening infection that impacts millions of people worldwide," said Eugene Schiff, MD, Chief of the Division of Hepatology and Director of the Center for Liver Diseases at the University of Miami School of Medicine. "We've made great progress in our ability to diagnose and treat the disease, but a significant unmet medical need remains and ongoing efforts in research and development are essential."
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Gilead Submits Marketing Applications In USA & EU For Viread® For The Treatment Of Chronic Hepatitis
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