GSK's Investigational Medicine for Liver Disease Secures US Breakthrough Therapy, EU Priority Medicines Designations
Idag, 17:21
Idag, 17:21
11:21 AM EDT, 04/27/2026 (MT Newswires) -- GSK's (GSK.L) efimosfermin, an investigational, subcutaneous injection, received the breakthrough therapy designation in the US and the priority medicines designation in Europe.
The designations, granted by the US Food and Drug Administration and the European Medicines Agency, recognize the potential of efimosfermin as treatment for metabolic dysfunction-associated steatohepatitis, or MASH, a serious liver disease, according to a Monday release.
The regulators'decisions were based on the drug's mid-stage trial in MASH patients with moderate to advanced and cirrhotic fibrosis, which showed fibrosis improvement and MASH resolution at 48 weeks after once-a-month efimosfermin treatment, compared with placebo.
Idag, 17:21
11:21 AM EDT, 04/27/2026 (MT Newswires) -- GSK's (GSK.L) efimosfermin, an investigational, subcutaneous injection, received the breakthrough therapy designation in the US and the priority medicines designation in Europe.
The designations, granted by the US Food and Drug Administration and the European Medicines Agency, recognize the potential of efimosfermin as treatment for metabolic dysfunction-associated steatohepatitis, or MASH, a serious liver disease, according to a Monday release.
The regulators'decisions were based on the drug's mid-stage trial in MASH patients with moderate to advanced and cirrhotic fibrosis, which showed fibrosis improvement and MASH resolution at 48 weeks after once-a-month efimosfermin treatment, compared with placebo.
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