In this third part of a three-part series, Steven D. Pearson, M.D., M.Sc., founder and president of ICER talks the drug Inclisiran and its relation to PCSK9 inhibitors.
Below is a short Q&A excerpt of an interview with Steven Pearson of ICER. Text has been edited for length and clarity.
Q: Is inclisiran a PCSK9 inhibitor?
A: I would probably shy away from calling it in the same class just because that has some technical kind of meaning, but its therapy will be very similar. Now, a couple of things, our report is done, but the FDA has not yet formally decided whether to approve this drug or not. They haven't been able to get overseas to check the factories and there's some interesting issues there. It's also a drug that even though it's administered, it's done just twice a year, as opposed to every two weeks.
There's a feeling that may have some for some patients in particular, a clinical benefit, because they can get it in the doctor's office and make sure that they get it when they come in for their biannual visit for many of these patients. There's a sense that it may provide a nice addition to the armamentarium of doctors who are always looking for new ways to make sure that patients bring their cholesterol down.
The other thing about this drug is not only is it not FDA approved, but again, at this stage, we don't have a clinical trial results on strokes, heart attacks and mortality that will come again in a few years. So we're kind of assuming for the time being the reduction in cholesterol will kind of translate through into those good outcomes for patients in the same way. But we'll know more in a couple of years, and we may need to revise our report.