By Suzanne Hodsden
Regeneron and Sanofi have developed a new cholesterol-lowering biologic, Alirocumab which has been found effective in high-risk patients with statin intolerance. The drug recently completed six phase 3 drug trials in which it met all of its primary endpoints and showed greater efficacy than competitive drugs, Reuters reports.
Millions of Americans are currently taking statins for the life-long management of high cholesterol levels, which are linked to cardiovascular disease. As with any medication which is taken over a long period of time, statins can cause significant side effects which must be closely monitored by the prescribing physician.
According to the FDA, these risks include liver damage, diabetes, reports of memory loss, and potential muscle and skeletal damage. Some patients must discontinue statin therapy due to the severity of these symptoms.
One of the phase 3 trials studying the efficacy of Alirocumab in 360 patients deemed statin intolerant showed a 45 percent reduction in LDL levels after 24 weeks. This is in comparison to Merck’s Zetia, another statin alternative, which the study found reduced LDL levels by only 14.6 percent.
Patrick Moriarty, a lead investigator of the drug who presented findings this past week at the American Heart Association conference in Chicago, remarked, “It’s more potent and more effective lipid lowering drug, getting patients to goal by a 10 fold higher amount.”
The trials, which studied around 2,400 patients in total, found that a third of patients already taking statins found their LDL levels almost eliminated from their bloodstreams.
Kausik Ray, another investigator told The Telegraph that “around 40 percent of people who took it saw their levels reduced to that of a newborn. This is the biggest reduction we’ve seen since statins were introduced.”
Alirocumab is a fully human monoclonal antibody targeting PCSK9, a protein which has been found to block the liver’s ability to process LDL out of the blood stream.
According to Reuters, Regeneron and Sanofi plan to file applications with the FDA and EMA later this year.