FDA delays NDA approval of Abilify 'digital medicine'

The US Food and Drug Administration has issued a complete response letter (CRL) for Otsuka Pharmaceutical (TYO: 4578) and Proteus Digital Health “digital medicine,” a drug/device combination product, which combines Otsuka’s Abilify (aripiprazole), an atypical antipsychotic, with the FDA-cleared Proteus ingestible sensor embedded in a single tablet at point of manufacture.

The NDA was submitted as a system that measures medication adherence to aripiprazole to be indicated for the treatment of schizophrenia, as an acute treatment of manic and mixed episodes associated with bipolar I disorder (BP1) and as an adjunctive treatment for major depressive disorder (MDD).

CRL calls for additional information