A review of select agents in late-stage development for the treatment of arrhythmia, congestive/chronic heart failure, and pulmonary hypertension (PDF) (January 2005)
FDA Sets PDUFA Date for Acoramidis in Heart Failure Indication
The FDA has set an action date of Nov. 29, 2024, to review acoramidis to treat patients with transthyretin amyloid cardiomyopathy.
Express Scripts Lists Inpefa as Preferred on Medicare Formularies
Inpefa is an inhibitor of both SGLT2 and SGLT1, approved to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. The wholesale acquisition cost is $598 per month.
FDA Issues Complete Response Letter for Onpattro in Heart Failure Indication
Alnylam 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 Grants Priority Review for Sotatercept in Pulmonary Arterial Hypertension
Sotatercept is a first-in-class therapy to treat the rare disease pulmonary arterial hypertension. The FDA has assigned a target action date of March 26, 2024.
FDA Advisory Committee Backs Use of Onpattro in Heart Failure Indication
Even 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.
FDA Approves First Anti-inflammatory Drug for Cardiovascular Disease
Lodoco targets the inflammation that is an underlying cause of atherosclerotic cardiovascular disease. It will be available in the second half of 2023.
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