Press Release
☷FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy
Food and Drug Administration ( By Press Release office)
Mar 23,2024
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Hey , great news! The FDA just approved Duvyzat ( givinostat ) oral medication for treating Duchenne Muscular Dystrophy ( DMD ) in patients six years and older . It ' s the first nonsteroidal drug to treat all genetic variants of DMD . Duvyzat works by reducing inflammation and muscle loss . The FDA is stoked about this new treatment option for DMD , which is a rare neurological disorder that causes muscle weakness and can lead to early death . Duvyzat was shown to be effective in a study , with patients showing less decline in muscle function compared to those on a placebo . Common side effects include diarrhea , abdominal pain , and nausea . Health care providers should monitor platelet counts and triglycerides before prescribing Duvyzat . Patients with a platelet count lower than 150 x 10^9/L should avoid taking Duvyzat . It ' s important to keep an eye on platelet counts and triglycerides while on this medication to see if any dosage adjustments are necessary . Moderate to severe diarrhea may also require changes in dosage . Duvyzat can potentially cause QTc prolongation , which may lead to irregular heartbeats . Patients who are already taking medications that can prolong QTc or have certain heart conditions should steer clear of Duvyzat . The recommended dose of Duvyzat is based on the individual ' s weight and should be taken orally twice a day with food . The FDA expedited the review process for this medication and granted it special designations . Italfarmaco S . p . A . is the company behind the approval of Duvyzat .
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