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Do Mixed Results Impact Potential Real-World Effectiveness and Potential Market Adoption?


In this Pharmaceutical Executive video interview, Optum Rx clinical pharmacist, Arash Sadeghi, explore mixed trial results impact the confidence in their potential real-world effectiveness and potential market adoption.

The trials presented for Roluperidone and Sotatercept had limitations, with mixed results or focused populations. How do these limitations impact the confidence in their potential real-world effectiveness and potential market adoption?

I'll focus on sotatercept because with roluperidone, again, didn't get approved. And so, I don't think it's going to have really any impact in the near term. But for sotatercept, I think there's two main considerations or questions. So, the first is that in the study, it was used as an add on treatment. So, patients in the study, were already on at least two or three other classes of drugs for PH, so 95% of patients were on at least two other drugs that are currently approved for PH. So, I think in the real world, this is likely going to be reserved as an option after patients have exhausted at least two or three other medications. So, it's not a first line product, but certainly could be used as an add on in patients who continue to be symptomatic or continue to need additional treatment. So that's one thing, it's going to have a more of a narrower population initially, because it's going to be in patients who have already started other drugs first.

The other question is really more around the data. So, the short-term results of the study appear promising. So, they in the short term, they show that they improve exercise capacity. So basically, what they showed was that they do a six-minute walk test, they basically have a patient walk for six minutes, and see how many meters they can walk, and then they reevaluate them throughout the study. And that's a good way to show the patient has shown as demonstrated improvement in exercise capacity. It's used in other PH studies and other conditions. So, they did show improvements in that endpoint, but we don't know what the long-term durability if you don't know what the long-term effect is, with the drug, especially on kind of harder clinical outcomes, how does it impact mortality? How does it out, you know, impact other outcomes associated PH? We don't have that long term data. So that's really the question I think around the data. And that's always a result of you know, having you know, a drug gets approved, you aren’t always going to have the full picture the full long-term data until it's used in practice.

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