Regeneron and Sanofi announce new Praluent injection analyses presented at AHA scientific sessions 2015
74% of patients reached their LDL cholesterol goals on 75 mg dose; Of the remaining patients whose dose was adjusted to 150 mg, most achieved their goal.
Regeneron Pharmaceuticals and Sanofi have announced a new post-hoc analysis of six Phase III clinical trials showing that approximately three quarters (74%) of patients reached their pre-specified LDL cholesterol targets within 8 weeks of adding Praluent (alirocumab) Injection 75 mg to their standard-of-care, which included statins. In the 26% of patients whose dose was increased to 150 mg, most were able to achieve their pre-specified LDL cholesterol target, with an average additional 14% reduction in LDL cholesterol. The results from this and other analyses, which evaluated Praluent every 2 weeks, were presented at the American Heart Association (AHA) Scientific Sessions in Orlando, FL.
"In this analysis of patients who required further improvement of their LDL cholesterol levels, adding Praluent 75 mg to their standard-of-care allowed the majority of patients to achieve their LDL cholesterol goals. For those who required further LDL cholesterol lowering, increasing Praluent to 150 mg provided additional efficacy," said Harold Bays, from the Louisville Metabolic & Atherosclerosis Research Center, Kentucky, US. "Data such as these provide clinicians practical insight as to how the two Praluent doses may better allow patients to achieve their LDL cholesterol goals."
These results are based on a pooled post-hoc analysis of 1,291 patients with high cardiovascular (CV) risk or an inherited form of high cholesterol (heterozygous familial hypercholesterolemia, or HeFH) which found 74% of patients who added Praluent 75 mg achieved their LDL cholesterol-lowering goals at week 8, and the remaining 26% had their dose adjusted to 150 mg at week 12. In other results:
In a separate pooled post-hoc analysis of 3,499 patients, individuals with diabetes (n=1,051) who initially received Praluent 75 mg or 150 mg every 2 weeks had a mean percent difference in LDL cholesterol of 44% and 58%, respectively, versus placebo at week 24 (p less than 0.0001). In other results:
A third post-hoc analysis of 4,974 patients did not find an increased risk of diabetes-related AEs among those who didn't have diabetes when they entered the trials, regardless of whether they were taking Praluent or were in a control group (placebo or ezetimibe). There was also no evidence that Praluent affected the incidence of new-onset diabetes or pre-diabetes. The ongoing ODYSSEY OUTCOMES trial will provide further data on the impact of Praluent on glycemic measures.
Related News
-
News CPHI Podcast Series: The power of proteins in antibody drug development
In the latest episode of the CPHI Podcast Series, Lucy Chard is joined by Thomas Cornell from Abzena to discuss protein engineering for drug design and development. -
News Amgen sues Samsung biologics unit over biosimilar for bone disease
Samsung Bioepis, the biologics unit of Samsung, has been issued a lawsuit brought forth by Amgen over proposed biosimilars of Amgen’s bone drugs Prolia and Xgeva. -
News CPHI Podcast Series: Why we need to consider women in clinical trials
The latest episode of the CPHI Podcast Series with Lucy Chard covers women's health, specifically women's representation in clinical trials, the associated bias, and the impacts on health for this population. -
News US FDA does not approve MDMA therapy for PTSD, requests more data
The MDMA-based therapeutic developed by Lykos Therapeutics, a California-based Public Benefit Corporation (PBC), has been reviewed and unapproved by the US FDA. The regulator has requested additional phase III trial data for further safety and efficacy... -
News Novartis and Viatris latest facing lawsuit over HeLa cell misuse
Global pharmaceutical companies Novartis and Viatris are the latest hit with a lawsuit claim pertaining to alleged misuse of the ‘HeLa’ cell line from the estate of woman whose cancerous tissue cells were taken without consent. -
News Sanofi invests billions into Frankfurt insulin production site
French pharmaceutical company Sanofi have announced an investment of EUR1.3 billion at their existing BioCampus site in Frankfurt am Main for the expansion of insulin production. -
News Novel oral Type 1 diabetes drug gains US FDA IND designation
A University of Alabama at Birmingham startup has gained FDA clearance for Investigational New Drug clinical trials for an oral Type 1 diabetes drug, a milestone for diabetes treatment. -
News A Day in the Life of a Vice President in R&D & Engineering
In the Day in the Life of Series, we've already had the chance to get to know a range of people in various roles in the pharma industry. In the latest interview we get a glimpse into the R&D side of things from Jennifer Sorrells, Vice Presiden...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance