Proven­tion's sec­ond shot at FDA ap­proval for di­a­betes pre­ven­tion drug hits new hur­dle

The long trek to­ward FDA ap­proval for teplizum­ab is still get­ting longer.

Proven­tion Bio said the agency is de­lay­ing a de­ci­sion on its drug, which is de­signed to stave off type 1 di­a­betes, by an­oth­er four months, mov­ing the PDU­FA date from Au­gust to mid-No­vem­ber.

This is the biotech’s sec­ond BLA af­ter the reg­u­la­tors hit its first at­tempt at ap­proval with a com­plete re­sponse let­ter. But the sto­ry for teplizum­ab goes back more than three decades, start­ing in the lab of for­mer UCSF sci­en­tist Jef­frey Blue­stone and pass­ing through Macro­Gen­ics and Eli Lil­ly — where it was put on life sup­port af­ter fail­ing a piv­otal tri­al — be­fore land­ing at Proven­tion, with some sup­port from Blue­stone.

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