Clinical

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

Articles

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.

Study: Heart Failure Patients Could Save with Inflation Reduction Act 


A phase 3 study demonstrated that Onpattro improved functional capacity, health status and quality of life compared with placebo in this patient population.


Alnylam Submits sNDA for Onpattro in ATTR Amyloidosis with Cardiomyopathy

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.

FDA Accepts sBLA for Evkeeza for Children with Rare High Cholesterol 


If approved, Xphozah will be the first phosphate absorption inhibitor for adults with chronic kidney disease who are on dialysis. An FDA decision is expected within 30 days.


FDA Advisory Committee Supports Xphozah in CKD

Furoscix can be administered at home with the use of the On-Body Infusor, which delivers furosemide over five hours. It will be launched in the first quarter of 2023.

FDA Approves Heart Failure Therapy that Provides an Alternative to Hospital Treatment 

Results indicated the trial is unlikely to meet its primary endpoint, the change from baseline in the six-minute walk test at 24 weeks.  

Pfizer Discontinues Late-Stage Cardiomyopathy Trial

A novel therapy in early development aims to permanently turn off the PCSK9 gene in the liver and lower cholesterol with a one-time treatment. It is being developed for a genetic form of high cholesterol.

First Patient Dosed in Trial of “Gene Editing” Medicine

Now called Camzyos, the therapy is first-in-class and treats the underlying cause of the disease. It is expected to be available next week.

FDA Approves Mavacamten for Hypertrophic Cardiomyopathy

The recall of Accuretic and generics distributed by Greenstone is a result of the presence of a cancer-causing agent.

Pfizer Recalls Blood Pressure Drug Accuretic

But there is no significant difference in rate of hospitalization for major bleeding when Eliquis is compared with Xarelto or warfarin.

Cardiovascular