An experimental drug by Regeneron Pharmaceuticals and Sanofi SA was found effective in reducing the levels of “bad” cholesterol even at times when administered once each four weeks and not every two weeks.
The treatment, alirocumab, is a part of the growing class of injectable treatments that blocks PCSK9 a protein that is naturally occurring that inhibits the body’s liver from expelling the LDL cholesterol.
These drugs, known as PCSK9 inhibitors are for patients whose level of cholesterol do not drop a sufficient amount despite using statins like Libitor from Pfizer and those patients who are unable to tolerate the drug’s side effects.
Regeneron and Sanofi SA are racing with Amgen Inc and Pfizer to bring the inhibitors to market, which is expected one day to be worth billions of dollars if the biotech drugs can also significantly lower heart attacks as well as death as have statins.
One industry analyst said that before the beginning of 2016, close to 36 million patients in the European Union and United States are thought to be eligible to receive evolocumab by Amgen and alirocumab.
Amgen however has the head start in receiving approval of evolocumab since it submitted an U.S. Food and Drug Administration application last August.
Hoping to narrow the gap, Regeneron and Sanofi paid $67.5 million to BioMarin Pharmaceutical for a voucher that is might be able to speed up the review process of alirocumab.
The drug was tested with 803 patients with high cholesterol and a heart risk that was moderate to high.
In that study the patient was given a dose of 300mg once every four weeks versus a placebo, with more than two thirds of those patients already taking statins.
Another study evaluated the new treatment in 234 patients with high cholesterol, a heart risk that was rated high and/or a history of not being able to tolerate the statins.
That trial compared a dose of 150 mg given once every four weeks with a placebo.