Brief­ing docs for Aca­di­a's Alzheimer's-re­lat­ed psy­chosis re­sub­mis­sion re­veal an un­de­cid­ed FDA

In its quest to re­sub­mit its Alzheimer’s-in­duced psy­chosis drug Nu­plazid to the FDA fol­low­ing a CRL, Aca­dia Phar­ma­ceu­ti­cals will have to face an ad­vi­so­ry com­mit­tee lat­er this week. And agency of­fi­cials re­leased their brief­ing doc­u­ments ahead of the hear­ing Wednes­day, re­veal­ing a mixed bag of opin­ions.

FDA sta­tis­ti­cians found that the da­ta sup­port­ing Aca­dia’s re­sub­mis­sion, which com­pris­es sev­er­al post-hoc analy­ses of its pre­vi­ous piv­otal tri­al, did not ap­pear to con­clude the drug is ef­fec­tive in Alzheimer’s pa­tients. But Aca­dia al­so repo­si­tioned an ear­li­er study as the pri­ma­ry fo­cus of the ap­pli­ca­tion, and reg­u­la­tors seemed open to con­sid­er­ing this new ap­proach.

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