Ipsen's Bylvay fails Phase 3 trial in children with biliary atresia

Ipsen announced that its experimental therapy Bylvay did not meet its primary endpoint in a Phase 3 trial targeting biliary atresia in infants.

Biliary atresia is a rare pediatric liver disorder in which the bile ducts become obstructed, often requiring surgical intervention such as the Kasai procedure to restore bile flow.

The trial results mean the company will need to reassess the development path for Bylvay in this indication, and no regulatory submission is expected at this time.