Rofecoxib voluntarily withdrawn from market due to cardiovascular risk

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.

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.

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.

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.

Lodoco targets the inflammation that is an underlying cause of atherosclerotic cardiovascular disease. It will be available in the second half of 2023.

In an analysis, researchers determined that Inpefa is cost-effective at commonly accepted willingness-to-pay thresholds in treating patients with heart failure who have diabetes.