FDA announced today it has granted Breakthrough Therapy designation for MK-5172/MK-8742, an all-oral HCV regimen being developed by Merck. The company said its current research for the regimen is in “important HCV sub-populations such as patients with cirrhosis and those co-infected with HIV.” The drugmaker said it plans to present interim data on its ongoing Phase II trial at the 64th American Association or the Study of Liver Disease annual Meeting in Washington D.C., in early November.
Meanwhile, according to results from an American Journal of Cardiology paper, levels of anaceptrapib (the firm’s experimental heart drug) registered at 40% of the levels observed when patients were taking the drug daily—three months after patients stopped taking it. Anaceptrapib is intended to prevent heart attacks and strokes by raising HDL cholesterol levels. In a company statement, Merck, as reported by Forbes, noted: “Data from Phase 1 and Phase 2 studies of shorter duration indicated that the clearance time for anaceptrapib was estimated to be up to two years…At this time, it is unknown how long it will take anaceptrapib to completely clear from the body.”
