SPOTLIGHT -
Valdecoxib meta-analysis finds increased cardiovascular risk
FDA Extends Evkeeza Indication to Include Young Children
Evkeeza treats a rare form of high cholesterol. It is now approved for patients as young of 5 years of age.
FDA to Hold Advisory Committee Meeting on Onpattro for Heart Failure Indication
Alnylam is seeking approval for Onpattro’s use in cardiomyopathy related to transthyretin-mediated (ATTR) amyloidosis. The FDA set an action date of Oct. 8, 2023.
Study: Lower Rebates, and Lower Prices, Lead to Lower Patient Costs
In a real-world example, investigators found that lowered pricing of prescription drugs results in lower patient out-of-pocket costs, particularly for those patients with coinsurance.
Study: Heart Failure Patients Could Save with Inflation Reduction Act
The Inflation Reduction Act’s cap on annual out-of-pocket spending and changes to coverage gaps could save Medicare patients more than $1,000 on heart failure medications.
Alnylam Submits sNDA for Onpattro in ATTR Amyloidosis with Cardiomyopathy
A phase 3 study demonstrated that Onpattro improved functional capacity, health status and quality of life compared with placebo in this patient population.
FDA Accepts sBLA for Evkeeza for Children with Rare High Cholesterol
If approved, Evkeeza would be the first treatment to help children as young as 5 years old control high LDL cholesterol caused by homozygous familial hypercholesterolemia. The FDA target action date is March 30, 2023.
