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GSK's Efimosfermin Receives FDA, EMA Designations for MASH

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-- GSK (GSK) said Monday its liver therapy efimosfermin received Breakthrough Therapy Designation from the US Food and Drug Administration and Priority Medicines designation from the European Medicines Agency for the treatment of metabolic dysfunction-associated steatohepatitis, or MASH.

The FDA designation is intended to expedite the development and review of medicines, while the EMA designation provides scientific and regulatory support.

The designations were supported by phase 2 data in patients with moderate to advanced and cirrhotic fibrosis, which showed improvement in liver fibrosis and MASH resolution versus placebo. The company said the therapy demonstrated a generally well-tolerated safety profile.

Phase 3 trials in MASH patients with cirrhotic fibrosis are expected to start this year, the company said.

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