In an­oth­er set­back, Ka­ma­da pulls an ap­pli­ca­tion at the EMA and re­trench­es on a PhI­II drug

Two weeks af­ter Shire punt­ed rights to one of its ther­a­pies, Is­rael’s Ka­ma­da $KM­DA says that it is yank­ing its mar­ket­ing ap­pli­ca­tion at the EMA for its in­haled ther­a­py for rare cas­es of Al­pha-1 An­tit­rypsin De­fi­cien­cy af­ter con­clud­ing that reg­u­la­tors will want to see da­ta from an­oth­er tri­al be­fore they con­sid­er hit­ting the green light.

Ka­ma­da pro­vid­ed post-hoc da­ta to back its case on a sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly rel­e­vant im­prove­ment in lung func­tion among pa­tients, but Eu­ro­pean reg­u­la­tors weren’t buy­ing it.

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