Ipsen withdraws NDA for rare bone disease treatment less than 3 months after winning priority review

After winning priority review for its ultra-rare bone disease program at the end of May, Ipsen made an abrupt about-face Friday.

Ipsen withdrew its NDA for palovarotene following discussions with the FDA indicating additional data analyses would be needed from two pivotal trials, the Paris biotech announced. The move came as a surprise to some as Ipsen had made strides to resolve issues stemming from a partial clinical hold in 2019 and a failed futility test soon after.