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Top FDA Drug Approvals in 2015: High Cholesterol

High cholesterol is a growing problem among Americans. A significant number of those who suffer from it rely on expensive treatments in their quest for longer, happier lives. Changing the landscape are two new cholesterol-busting drugs approved this summer which could eventually spell relief for no fewer than 76 million Americans.

In this video segment, Motley Fool analyst Kristine Harjes and contributor Todd Campbell discuss these new drugs and how they work with existing treatments to provide optimum results for patients with cholesterol issues.

A full transcript follows the video.

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This podcast was recorded on Dec. 2, 2015.

Kristine Harjes: OK, so let's kick it off. We'll start with the double-trouble summer approval of two drugs marking a new class of cholesterol treatment. Todd?

Todd Campbell: Boy, I tell you, narrowing this list down to just a few that we talk about in the time that we have was tough, because there are a lot of good drugs. I'm sure that when people were thinking of what drugs we would discuss, I'm sure a lot of people will be disappointed -- why didn't you pick my drug? But that being said, we had to make some judgment calls, and the first one as you mentioned that I think is a needle mover and a potential game changer is the approval of two brand-new cholesterol-busting drugs: Sanofi and Regeneron won approval for their drug Praluent back in July, and Amgen won an approval for their cholesterol-fighting drug a month later. And that drug is named Repatha.

Harjes: Right. And these two really just marked a whole new wave of how we look at cholesterol treatments. I mean, people have been taking drugs called statins forever. I mean, not actually forever, but for years. I mean 25 million or so Americans use statins. And meanwhile, 76 million Americans have elevated bad cholesterol. So this is a huge, huge market, and to have two drugs that target this problem in a different way could really be a game-changer for a lot of people.

Campbell: Oh, big time. You know, you've got 600,000 people a year dying from heart disease. It's a major issue. You've got, as you mentioned, 76 million people with elevated cholesterol levels. And while you know, these new drugs have not been proven to actually reduce or eliminate the risk of a heart attack, a stroke, or improve mortality for the condition, it's been generally thought that if you can lower cholesterol, then you will lower the risk of these events happening.

Harjes: Yeah.

Campbell: And I think that that's one of the reasons the statins have become so widely used. I mean, this is the most-prescribed drug out there. And you know, as a result, the cholesterol-lowering statins were some of the best-selling drugs over the last 30 years. I think the first one came to the market in the '80s. By the mid-'90s this was billion dollar category. In the 2000s, Lipitor changed the entire paradigm of what people spend on drugs with the Lipitor that was bringing in $13 billion a year in sales.

I'm not saying that these drugs will get that level, but the ability to lower cholesterol by an additional 60% beyond what statins do, that's already pretty darn game-changing.

Harjes: Yeah, it's really interesting when you dig into how exactly these drugs work. So they're called PCSK9 inhibitors, by the way. That's the class name. So basically, PCSK9 is a protein that destroys bad cholesterol receptors in the liver. So if you limit it, then you get more cholesterol being cleared from the bloodstream. And so this is a totally different mechanism than statins, which reduce cholesterol production.

So the thinking here is you use both of them and you're kind of coming at the issue from both sides of it. And it's worked really well so far in trials.

Campbell: Yeah, I mean lowering cholesterol again by 60% when used alongside maximum statin therapy could be, it's incredibly significant to make a difference for thousands and thousands of patients worldwide every year. There's some challenges, obviously, as far as pricing is concerned, because these are not cheap drugs. And of course this affects millions of people. So figuring out how to pay for it, who should actually get the drugs, who shouldn't, all of that is going to have to be watched very closely over the course of the next year. But without a doubt, this is a pretty important set of approvals.

The article Top FDA Drug Approvals in 2015: High Cholesterol originally appeared on Fool.com.

Kristine Harjes has no position in any stocks mentioned. Todd Campbell has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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