Signal FDA accepts EIT Pharma's NDA for lonafarnib to treat chronic hepatitis D

Summary

The US Food and Drug Administration officially accepted EIT Pharma's New Drug Application review for lonafarnib. Lonafarnib is a first-in-class oral treatment candidate for chronic hepatitis D. The compound previously received FDA Breakthrough Therapy designation. If it wins final approval, it would become the first oral treatment for chronic hepatitis D available in the United States. The acceptance is seen as a step toward closing a treatment gap in a rare liver disease with few existing options.