- Olezarsen met the primary endpoint with a statistically significant reduction in triglyceride levels versus placebo
- First study to show an absolute reduction in acute pancreatitis in FCS patients, with olezarsen 80 mg monthly dose reducing events by 100 percent
- Olezarsen demonstrated a favorable safety and tolerability profile
- Ionis plans to file a New Drug Application with U.S. FDA in preparation for first potential independent launch
News Stories
The United States Preventive Services Task Force (USPSTF) recently released its Final Recommendation Statement on Lipid Disorders in Children and Adolescents: Screening. NLA leadership disagrees with this release and communicated twice to USPSTF about the implications of this statement. The USPSTF has made no acknowledgment of the NLA’s concerns.
Novartis received FDA approval for a label update that will allow for use of Leqvio ® (inclisiran) in certain patients at high risk of cardiovascular (CV) disease. This broader population allows for earlier Leqvio treatment in patients with elevated low-density lipoprotein cholesterol (LDL-C) and CV risk factors, such as diabetes and hypertension, who are at increased risk of atherosclerotic cardiovascular disease (ASCVD), beyond the previously approved ASCVD and heterozygous familial hypercholesterolemia (HeFH) patient population.