FDA Issues CRL to Otsuka for Digital Medicine, Seeks More Data

A complete response letter to Otsuka Pharmaceutical from the FDA shot down the company’s application for a drug/device combination product, saying the agency needs more data.

The letter says that the submission for the product — an ingestible sensor embedded in the company’s antipsychotic drug Abilify — needs more data relating to drug performance “under conditions in which it is likely to be used,” as well as additional risk information, the Japanese company disclosed.

Otsuka says it will cooperate with the agency to address its questions and provide more data on the product’s NDA. An Otsuka spokeswoman said that the company is in the process of reviewing the agency’s request but doesn’t know when it will have the data ready.