Take­da pulls dengue vac­cine ap­pli­ca­tion af­ter FDA re­quests more da­ta

Take­da has with­drawn an FDA ap­pli­ca­tion for its dengue vac­cine can­di­date fol­low­ing a re­quest by reg­u­la­tors for more da­ta.

The Japan­ese biotech filed a bi­o­log­ics li­cense ap­pli­ca­tion for TAK-003 last year, an­nounc­ing in No­vem­ber that it scored pri­or­i­ty re­view sta­tus, which typ­i­cal­ly short­ens the FDA’s de­ci­sion-mak­ing process to six months. On Tues­day, how­ev­er, the com­pa­ny re­vealed that it vol­un­tar­i­ly pulled the BLA af­ter reg­u­la­tors “sought ad­di­tion­al da­ta not cap­tured with­in the TAK-003 clin­i­cal tri­al pro­to­col,” which the agency had pre­vi­ous­ly re­viewed and ac­cept­ed.

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