CEE alone increases stroke risk in post-menopausal women
Findings from a newly released Women's Health Initiative (WHI) study suggest that conjugated equine estrogen (CEE) alone should not be used for chronic disease prevention, specifically coronary heart disease (CHD), in postmenopausal women. The study, published in the Journal of the American Medical Association, found that CEE increased the risk of stroke by 39% and offered no protection against heart disease.
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.
