Rosuvastatin: A new HMG0CoA reductase inhibitor for hypercholesterolemia (PDF)
Rosuvastatin is an investigational HMG-CoA reductase inhibitor expected to gain FDA approval later this year for treatment of hypercholesterolemia. It has significantly exceeded atorvastatin, pravastatin, and simvastatin in reducing LDL cholesterol in clinical trials. This Focus article reviews those trials as well as rosuvastatin's pharmacologic and safety profiles in an effort to delineate its likely role in cholesterol-reducing therapy.
FDA Issues Complete Response Letter for Onpattro in Heart Failure Indication
October 9th 2023Alnylam Pharmaceuticals will no longer pursue this indication of Onpattro and will instead on focus on a label expansion for Amvuttra, which is in phase 3 development to treat patients with cardiomyopathy of ATTR amyloidosis.
FDA Advisory Committee Backs Use of Onpattro in Heart Failure Indication
September 16th 2023Even though committee members voted in support of Onpattro for patients with cardiomyopathy related to transthyretin-mediated amyloidosis, there were questions about whether it provided a clinically meaningful benefit. The FDA set an action date of Oct. 8, 2023.
