News Releases
Regeneron and Sanofi Announce Positive Results for Cholesterol Drug
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that two new ODYSSEY trials, which are the first Phase 3 trials to assess alirocumab administered every four weeks, met their primary efficacy endpoints.
Lipid Lowering Med Liptruzet Now FDA Approved
Merck, known as MSD outside the United States and Canada, today announced that the US Food and Drug Administration (FDA) has approved LIPTRUZET™(ezetimibe and atorvastatin) tablets.
Merck’s LIPTRUZET Approved by the FDA
Merck, known as MSD outside the United States and Canada, today announced that the US FDA has approved LIPTRUZET™(ezetimibe and atorvastatin) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.
Merck Expects FDA's Review for Ezetimibe Atorvastatin
Merck (NYSE: MRK ), known as MSD outside the United States and Canada, announced today that the US Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for ezetimibe and atorvastatin tablets, an investigational combination medicine.
FDA Approves Juxtapid for Homozygous Familial Hypercholesterolemia
Aegerion Pharmaceuticals, Inc. today announced that the US Food & Drug Administration (FDA) has approved JUXTAPID™ ( lomitapide ) capsules as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol ( LDL-C ), total cholesterol ( TC ), apolipoprotein B ( apo B) and non-high density lipoprotein cholesterol ( non-HDL ) in patients with homozygous familial hypercholesterolemia ( HoFH ).
Sanofi and Regeneron Report Phase 2 Results for Lipid Drug
Sanofi and Regeneron Pharmaceuticals, Inc. announced that data from two Phase 2 trials with
SAR236553 / REGN727 , an investigational, high-affinity, subcutaneously administered, fully-human
antibody targeting PCSK9 ( proprotein convertasesubtilisin / kexin type 9), were presented at the
American College of Cardiology’s (ACC) 61st Annual Scientific Meeting in Chicago.
Sanofi, Regeneron Make Strides With Cholesterol Drug
Sanofi and Regeneron Pharmaceuticals, Inc. announced positive preliminary results from the Phase 2 study program in which patients with elevated low-density lipoprotein cholesterol (LDL-C) were treated with REGN727/SAR236553.