FDA again reviewing Abilify with Proteus' sensor

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) and Proteus Digital Health Inc. (Redwood City, Calif.) said FDA has accepted for review a resubmitted NDA for antipsychotic Abilify aripiprazole with an ingestible sensor from Proteus in a single tablet. The partners expect a regulatory decision in 4Q17.

In April 2016, FDA issued a complete response letter for the combination product. The agency had requested additional human factors investigations and performance data under the conditions in which the digital medicine is likely to be used (see BioCentury Extra, April 27, 2016). ...