Eplerenone is a selective aldosterone receptor antagonist under FDA review for treatment of hypertension. With a high trough-to-peak ratio, it is suitable for once-daily dosing. It significantly reduces blood pressure in patients with mild to severe hypertension and can be used alone or in combination with other antihypertensives. Although chemically related to spironolactone, eplerenone has a lower binding affinity for androgenic and progestogenic receptors than spironolactone, which may translate into a lower incidence of endocrine-related adverse effects. In addition, eplerenone lowers blood pressure particularly well in patients with low-renin, salt-sensitive hypertension, such as African Americans.
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.