Initiating high-dose simvastatin (Zocor, Merck) early after an acute coronary syndrome (ACS) event does not result in significantly superior clinical outcomes compared to delayed initiation of low-dose simvastatin.This major finding of phase Z of the A to Z Trial is in contrast to the results of 2 previous clinical trials in which aggressive therapy with atorvastatin (Lipitor, Pfizer) was found to be superior to less aggressive statin therapy in reducing the risk of adverse clinical events in ACS patients.
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.