The late-stage study for the injectional drug Praluent, commercialized by Sanofi (EPA: SAN) and Regeneron Pharmaceuticals (NASDAQ: REGN), showed promising results in patients whose cholesterol levels require constant apheresis therapies, a process similar to kidney dialysis which aims to remove bad cholesterol (LDL) from the blood.
In the Phase 3 of the trial evaluating the drug, it was demonstrated that Praluent reduced by 75 percent the frequency of the apheresis therapy in patients who added the drug to its existing treatment, compared to the control group where the frequency was not reduced at all, according to a press release made by the French drugmaker, Sanofi.
In addition to that, 63 percent of the patients treated with the drug no longer require the chronic therapy, compared to zero percent of placebo patients. The study consisted of more than 25,000 patients and their apheresis therapy frequency was adjusted based on the patient’s LDL cholesterol response to treatment.
“This is the first time a PCSK9 inhibitor has shown in a clinical study that it reduced the frequency of apheresis therapy, an invasive, difficult to access, time-consuming and expensive treatment for some of the most difficult-to-treat patients,” said Bill Sasiela, Ph.D., VP and Program Director at Regeneron.
The trial was designed to understand the effect of Praluent on many different patients populations with a high degree of unmet need who require further reduction of their LDL cholesterol, added Sasiela.
An extra help to a pricey treatment
The dialysis-like therapy has been qualified as invasive and burdensome by many patients, and even highly expensive by others. The therapy can be required once or twice per week and a single session can last about three hours.
Apheresis therapy also can cost up to $100,000 for each patient per year in the U.S and up to €60,000 in Germany, where there are 200 centers and the therapy is more frequently used.
According to the press release made by the pharmaceutical companies, in the U.S there are approximately 60 centers that offer the therapy and many patients must travel significant distances to get the pricey treatment they require.
The results of the study demonstrated that treatment with Praluent may help these patients decrease the frequency or even eliminate the need for the therapy, said Doctor Jay Edelberg, head of cardiovascular development at Sanofi.