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GSK PLC on Monday announced two positive regulatory rulings for efimosfermin, a once-monthly investigational liver therapy. The London-based pharmaceuticals company said efimosfermin has been granted breakthrough therapy designation by the US Food & Drug Administration. In addition, the drug has been given Priority Medicines Designation by the European Medicines Agency for the treatment of metabolic dysfunction-associated steatohepatitis. MASH is a leading cause of liver transplant in the US and Europe. The FDA designation is designed to expedite the development and review of medicines for serious conditions, where preliminary clinical evidence indicates the potential for substantial improvement over available therapy. The EMA designation provides scientific and regulatory support for medicines that have the potential to address significant unmet medical need. The two rulings were supported by data from MASH patients with moderate to advanced and cirrhotic fibrosis. This includes phase II data at 48 weeks for patients who showed fibrosis improvement and MASH resolution with once-monthly efimosfermin versus placebo. Data also confirmed a well-tolerated safety profile with mild, transient adverse events. Efimosfermin is currently in phase III with the ZENITH-1 and ZENITH-2 trials investigating efficacy and safety in MASH patients with moderate to advanced fibrosis. Phase III trials in MASH patients with cirrhotic fibrosis are expected to start this year. Shares in GSK were down 0.5% at 2,009.00 pence each in London on Monday afternoon. Copyright 2026 Alliance News Ltd. All Rights Reserved.
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