Merck (MRK) Announces FDA Holds on Studies Evaluating Islatravir for the Treatment and Prevention of HIV-1 Infection
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Merck Announces Clinical Holds on Studies Evaluating Islatravir for the Treatment and Prevention of HIV-1 Infection
December 13, 2021 5:00 PM ESTKENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has placed clinical holds on the investigational new drug applications (INDs) for the oral and implant formulations of islatravir (MK-8591) for HIV-1 pre-exposure prophylaxis (PrEP); the injectable formulation of islatravir for HIV-1 treatment and prophylaxis; and the oral doravirine/islatravir (DOR/ISL) HIV-1 once-daily treatment. The FDAs clinical hold is based on previously announced observations of decreases in total lymphocyte and CD4+ T-cell counts in... More
