Isis/Genzyme's Kynamro meets primary endpoint in Phase III cholesterol trial

4 August 2015

American pharma company Isis Pharmaceuticals (Nasdaq: ISIS) has announced that its Phase III study of Kynamro (mipomersen sodium) met its primary endpoint.

The FOCUS FH trial looked at patients with severe heterozygous familial hypercholesterolemia, and met its primary endpoint, a statistically significant reduction in LDL-cholesterol after 60 weeks of treatment of once-weekly injections of 200mg Kynamro compared to placebo.

LDL-cholesterol reduction was similar to that observed in previous Phase III studies. In addition, based on the data available for review, the safety profile of Kynamro observed in the FOCUS FH trial was similar to the safety profile reported in previous Phase III studies. Genzyme, a Sanofi company (Euronext: SAN), which is commercializing the product, will provide a more in depth review of the safety and efficacy data.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK