- In clinical trials, alirocumab, co-developed by Regeneron and Sanofi, helped 10 times as many high-risk, statin-averse patients with hypercholesterolemia as Merck's Zetia (ezetimbe)—the first non-statin drug used to lower cholesterol.
- Many patients with hypercolesterolemia are unable to take statins due to the muscular and skeletal side effects.
- In a 24-week study of 360 patients with LDL-C level of 190 or higher, alirocumab lowered LDL-C by 45%, compared with 14.6% for Zetia.
Within the last few days, there has been a lot of about a study finding that Zetia actually works. But the treatment differences are relatively minor at 2%.
However, alirocumab seems to be a different story. As a PCSK9 inhibitor, alirocumab is seen as a newly emerging class that could significantly shift the cardiovascular disease treatment paradigm. Approval is anticipated in the EU and the U.S. sometime next year (depending on just how fast the review process proceeds), and the number of large pharmas vying for treatments in this class is sure to keep things interesting.