Please login to the form below

Not currently logged in
Email:
Password:

FDA accepts Genzyme-Isis cholesterol drug for review

Agency will analyse Kynamro’s ability to reduce levels of cholesterol in patients with rare genetic disorder

The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for Kynamro, a cholesterol-lowering drug developed by Isis and Sanofi's Genzyme business.

Kynamro (mipomersen sodium) is a novel treatment for patients with homozygous familial hypercholesterolaemia (HoFH) – a rare genetic condition that results causes the cells that process LDL cholesterol in the body to malfunction, leading to excess cholesterol.

It works by blocking the production of apolipoprotein B, a protein that is necessary in the formation of atherogenic lipoproteins that carry cholesterol through the bloodstream.

Isis and Genzyme submitted the application for Kynamro in March, 2012, and the FDA's decision to review the drug means that the drug's initial discoverer Isis is entitled to a $25m milestone payment from Genzyme.

The FDA will now analyse data from what Genzyme says is the largest clinical trial conducted in people with HoFH, and which demonstrated significant reductions in levels of LDL cholesterol among patients receiving Kynamor who were already receiving a regimen of lipid lowering therapies.

"The NDA filing with the FDA represents a significant achievement in the development of Kynamro and our efforts to get this important new drug to the market for patients who are at high-risk of a cardiovascular event,” said Dr David Meeker, president and CEO, Genzyme.

Isis and Genzyme also have plans to file the drug in other indications, expanding Kynamro's potential beyond homozygous familial hypercholesterolaemia, which is thought to affect about one in 1m people.

The partners have ongoing trials of Kynamro in severe heterozygous familial hypercholesterolemia (HeFH), another genetic condition that causes levels of cholesterol to rise and is thought to affect one in 500 people.

Other drugs currently in development for this condition include another Sanofi-owned treatment, SAR236553/REGN727, which the French pharma firm is developing with Regeneron.

The investigational product recently demonstrated positive performance in its ability to reduce LDL cholesterol in a phase II trial.

31st May 2012

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Anthill Agency

Anthill is a specialist digital agency and a strategic partner for life science companies....

Latest intelligence

What pharma marketers can learn from behavioural science
Pharma behavioural science and traditional emotional marketing create a powerful mix of techniques that have impact on real lives....
NEW EU DATA PROTECTION REGULATION POISED TO CHANGE DATA PRIVACY LANDSCAPE
NEW EU DATA PROTECTION REGULATION POISED TO CHANGE DATA PRIVACY LANDSCAPE The bold digital clock featured on the EUGDPR (EU General Data Protection Regulation)1 website indicates – to the second...
Health knowledge: Why is it so important?
Health knowledge plays an important role in population health, but by itself is rarely enough to prompt a change in the behaviours that cause the risks....

Infographics