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.

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