CNBC's Annika Kim Constantino joins 'Closing Bell Overtime' to talk changes coming out of the CDC and FDA.

Washington

The U.S. Food and Drug Administration is preparing to change its drug approval process by allowing certain medications to be approved based on the results of a single well-designed clinical trial, rather than the current standard of two. This adjustment is expected to streamline approvals, especially for drugs treating large populations, such as those for hypertension, diabetes, and obesity.

Pharmaceutical companies like Viking Therapeutics, which is developing an obesity drug currently in phase three trials, could benefit significantly from the new policy by saving time and resources. However, there is still uncertainty regarding how the FDA will handle ongoing trials, and further details are expected from the Department of Health and Human Services.

FDA plans drug approval changes

The health regulator reportedly saying one clinical trial can be just as informative as two When they're designed correctly cutting the number of trials would vastly streamline the drug approval process Obesity drug maker viking pharmaceuticals one big beneficiary today rising as much as 13 percent at its highs For more on this impact cnbc.com pharmaceutical reporter annika. Constantino joins us here on set annika. Welcome to the show. Welcome to fast money Thank you guys so much for having me. Uh, so this is a very interesting notion. They the fda says that typically It's already one and so they're just making this the default how much will actually change here, right? So here's why this really matters for you guys so there was a raymond james note that came out today that basically said You know, the biggest impact is going to be on drugs that treat large patient populations So when you hear that you think hypertension diabetes or obesity, which is what you really care about here and basically everywhere and so when you think of names like viking therapeutics, it makes sense why we saw the stock rise so much because You know when you think about these companies the amount of time and kind of effort they have to put into Doing these massive multi-trial phase three programs, you know It's going to save a lot of costs and a lot of time and a lot of risk If they only have to do one of these trials and so viking is such a great example of that So for viking specifically their obesity drug, the the leading candidate, right is a drug that's in phase three right now So under this new sort of regime if this actually happens They would be able to just get evaluated based on the data that's already in right so it's unclear yet What exactly is going to happen especially for drug makers that have phase three trials currently ongoing for their drugs? So it's unclear if the fda is going to say you don't need to finish that, you know You've enrolled now, but you don't need to finish that or just finish it anyway, because you've started it already So we need to get more details once there's an official press release out from hhs But what's interesting about viking is that you know, maybe one or two years ago This was really seen as a hot takeover target when it comes to the mna space But we've seen pharma kind of move away from that and look for more differentiated and cheaper assets like in china, for example and so this is good news for viking because it's going to be A company that might have to just really do this alone like commercialize their drugs alone when it gets to that approval point And so that's why it's good news for it You

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Breakdown