Cardiomyopathy

The FDA set the Prescription Drug User Fee Act (PDUFA) date for the investigational RNAi therapeutic as March 23, 2025.

With approval, acoramaidis becomes the first agent with a label specifying near-complete stabilization of TTR.

Sacubitril/valsartan reduced the risk of heart damage among high-risk cancer patients treated with anthracycline chemotherapy agents.

A single dose of nex-z achieved consistent and rapid reductions in serum TTR levels over 12 months of follow-up in patients with ATTR-CM.

Masri previewed data to be presented at the AHA 2024 Scientific Sessions and shared his excitement for the ongoing phase 3 trial of NTLA-2001.

The sNDA submission to the FDA included a Priority Review Voucher, which commits the regulatory agency to an accelerated review timeline.

A review of 5 highly anticipated FDA decisions expected by year-end, including acoramidis for ATTR-CM, olezarsen for FCS, sotagliflozin for T1D and CKD, and more.

EDG-7500 was well-tolerated in healthy patients in Phase 1 while achieving gradient relief without LVEF reductions in the Phase 2 CIRRUS-HCM trial.

Ahmad Masri, MD, MS, highlights a trio of studies from ESC Congress 2024 examining use of aficamten in hypertrophic cardiomyopathy.

MAVA-LTE trial data show mavacamten's sustained benefits in symptomatic obstructive HCM, with long-term improvements in LVOT, NT-proBNP, and quality of life.

HELIOS-B trial shows vutrisiran reduces all-cause mortality and CV events in ATTR-CM, with benefits consistent regardless of tafamidis use.

Vutrisiran achieved statistically significant reductions in primary and all secondary endpoints for patients with ATTR-CM in the HELIOS-B trial.

Our cardiology month in review spotlights the top 5 storylines that defined cardiology during May 2024, including new HCM guidelines, news from ESA 2024, and the FLOW trial.

The SEQUOIA-HCM trial presents aficamten as a promising treatment for symptomatic obstructive hypertrophic cardiomyopathy, showing significant improvements in multiple endpoints.

The latest guidance on hypertrophic cardiomyopathy contain new endorsements for the cardiac myosin inhibitor class and other aspects of management.

The April 2024 cardiology month in review spotlights FDA news and top updates from the American College of Cardiology 2024 Scientific Session.

Ahmad Masri, MD, MS, discusses a study from ACC.24 examining trends in incidence and outcomes of emergency department visits related to hypertrophic cardiomyopathy from 2006 to 2019.

Sara Saberi, MD, discusses 1-year data from a cohort of 46 patients within the FOREST-HCM trial at ACC.24.