Michael J. Koren, MD,FACC,CPI served as an author and investigator for two new cholesterol-lowering treatments that passed a major hurdle for FDA clearance last week. Dr. Koren is one of only two physicians world-wide who has participated in the publication of key findings for these products in seminal publications in the New England Journal of Medicine.
Jacksonville, FL -- (ReleaseWire) -- 06/17/2015 --The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA met June 9th and 10th and recommended two products using a novel therapy for lowering the amount of low density lipoprotein (LDL) cholesterol in the blood.
These two injectable drugs, alirocumab (Praluent) and evolocumab (Repatha), are monoclonal antibodies which target a protein in the liver - PCSK9 (proprotein convertase subtilisin kexin 9). The inhibition of PCSK9 markedly reduces circulating LDL cholesterol, and is theorized to reduce cholesterol-related adverse events such as atherosclerosis, heart attack and associated negative cardiovascular outcomes. In addition to contributing to numerous peer-reviewed articles regarding PCSK9 inhibitors, Dr. Koren is CEO of Jacksonville Center for Clinical Research which has conducted over 75 clinical trials involving hundreds of participants to evaluate this new class of medication. He states, "We are at a very exciting point in the development of these products. It's fabulous new science."
JCCR's on-going participation in clinical trials with PCSK9 inhibitors will continue to provide answers to the questions of long-term safety and efficacy.
Jacksonville Center for Clinical Research