Down but not out: FDA re­jects Proven­tion's di­a­betes drug as com­mer­cial prod­uct dif­fers from tri­al drug

In an ex­pect­ed and re­solv­able set­back for Proven­tion Bio, the FDA on Ju­ly 2 is­sued a com­plete re­sponse let­ter for the com­pa­ny’s Type 1 di­a­betes drug teplizum­ab af­ter find­ing the com­mer­cial prod­uct failed to show phar­ma­co­ki­net­ic com­pa­ra­bil­i­ty with the drug sub­stance man­u­fac­tured for clin­i­cal tri­als.

The com­pa­ny, which ac­quired teplizum­ab from Eli Lil­ly and showed signs of an in­com­ing CRL by an­nounc­ing the FDA’s PK con­cerns in April, not­ed that the FDA told the com­pa­ny, “As PK re­mains the pri­ma­ry end­point for demon­stra­tion of com­pa­ra­bil­i­ty be­tween the two prod­ucts, you will need to es­tab­lish PK com­pa­ra­bil­i­ty ap­pro­pri­ate­ly be­tween the in­tend­ed com­mer­cial prod­uct and the clin­i­cal tri­al prod­uct or pro­vide oth­er da­ta that ad­e­quate­ly jus­ti­fy why PK com­pa­ra­bil­i­ty is not nec­es­sary.”

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