FDA hits Mesoblast with CRL, ask­ing for more adult da­ta in acute graft-ver­sus-host dis­ease

The FDA hand­ed a com­plete re­sponse let­ter to Mesoblast for its BLA sub­mis­sion of its drug for pe­di­atric steroid-re­frac­to­ry acute graft-ver­sus-host dis­ease (SR-aGVHD), the com­pa­ny an­nounced Fri­day, adding an­oth­er de­lay in a wind­ing jour­ney for remestem­cel-L.

The agency wants more da­ta in adult pa­tients be­fore it will ap­prove the drug. Mesoblast said it’s plan­ning on a con­trolled study in high-risk adults whose pre­vi­ous ther­a­pies haven’t worked and whose 90-day sur­vival is as low as 20% to 30%. The adult study is in line with what it had planned to do in a se­quen­tial move from pe­di­atric to adult SR-aGVHD, as adults make up 80% of the mar­ket for the dis­ease, the com­pa­ny added in its state­ment.

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