FDA approval for cholesterol-lowering injections
A new injectible treatment for cholesterol has been approved by the FDA.
Genzyme and Isis Pharmaceuticals have received US Food and Drug Administration approval for a new drug application for Kynamrotm injections.
The mipomsersen sodium treatment, administered 200mg weekly in a subcutaneous fashion, has been approved as an additional treatment alongside lipid-lower medications to reduce low density lipoprotein-cholesterol (LDL-C), apoliprotein B and total cholesterol in patients with homozygous familial hypercholesterolemia (HoFH).
The rare condition involves the body being unable to properly process and remove LDL cholesterol from the blood, meaning that levels of so-called 'bad' cholesterol can rise significantly and result in cardiac arrest or mortality before the age of 30.
As a result of the approval, Genzyme will pay Isis $25 million in order to launch Kynamro commercially.
Dr Stanley T Crooke, chairman and chief executive of Isis, said: "Kynamro is the first systemic antisense drug to reach the market and is the culmination of two decades of work to create a new more efficient drug technology platform.
"We look forward to continuing to work with Genzyme toward a successful commercial launch of Kynamro and global expansion into other markets."
Related News
-
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare. -
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed.
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