With enoxaparin?s recent labeling change regarding its use in patients with prosthetic valves, clinicians may have several questions about appropriate anticoagulant selection. Specifically, what evidence prompted the labeling change, which patients are affected, what are the options and limitations for bridging patients, what?s the evidence supporting the role of low molecular weight heparins (LMWHs) in bridge therapy, and how can liability be limited should clinicians choose to use LMWH therapy? The authors of this commentary offer their insight on these issues.
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.