Story perspectives

FDA Approves Lynavoy for Severe Itching Relief in PBC

3/19/2026

Summary

Story summary

On March 19, 2026, the U.S. Food and Drug Administration (FDA) approved GlaxoSmithKline's Lynavoy for severe itching in primary biliary cholangitis, affecting over 100,000 U.S. adults.
Primary biliary cholangitis is an autoimmune disease that damages liver bile ducts.
A late-stage trial showed Lynavoy provides significant itch relief.
GlaxoSmithKline will let Alfasigma acquire exclusive development and commercialization rights.
Current PBC itching treatments are off-label and do not directly treat the symptom.

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Story summary

On March 19, 2026, the U.S. Food and Drug Administration (FDA) approved GlaxoSmithKline's Lynavoy for severe itching in primary biliary cholangitis, affecting over 100,000 U.S. adults.
Primary biliary cholangitis is an autoimmune disease that damages liver bile ducts.
A late-stage trial showed Lynavoy provides significant itch relief.
GlaxoSmithKline will let Alfasigma acquire exclusive development and commercialization rights.
Current PBC itching treatments are off-label and do not directly treat the symptom.