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Beyond hypertension: Evidence for use of angiotensin II receptor blockers in renal dysfunction and heart failure (PDF)
The evidence supporting a role for the angiotensin II receptor blockers (ARBs) in patients with nephropathy and/or heart failure continues to evolve. Currently, the FDA is in late-stage review of the first ARB for a heart failure indication and is reviewing another ARB for a diabetic nephropathy indication. The authors of this article present and interpret the clinical evidence for ARB use in these two disease states. Included in their discussion are the most recent recommendations on ARBs’ place in therapy according to the American Diabetes Association, the American College of Cardiology, and the American Heart Association.
FDA Approves Combination Therapy for Pulmonary Arterial Hypertension
March 25th 2024J&J’s Opsynvi is single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a PDE5 inhibitor. It will be priced on parity with Opsumit, which is also a J&J product to treat patients with PAH.
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.
