The regulatory clearance of the first smart drug which incorporates Proteus Digital Health’s ingestible sensor has came to its first stumbling block. Proteus and Otsuka Pharmaceuticals submitted the system as a new drug application (NDA) with the FDA in September 2015, and the Agency now declined to approve it.
“While we are disappointed in the FDA’s decision not to approve this digital medicine at this time, both Otsuka and Proteus are committed to working with the FDA to address its questions and provide the additional data that has been requested,” Robert McQuade, executive vice president and chief strategy officer, Otsuka Pharmaceutical Development & Commercialization, said in a statement. “We believe in the potential of this product to help people with serious mental illness manage their daily medication, which remains a serious unmet need.”
FDA issued a Complete Response Letter (CRL) to the two companies, laying out the additional steps a non-approved drug must take to secure approval. More precisely, the Agency asked for “data regarding the performance of the product under the conditions in which it is likely to be used, and further human factors investigations.” Said “human factors investigations” screen for risks related to human error and are meant to confirm a product can be used safely and effectively.
We have no doubts that the two companies will get past this setback and do all the additional work FDA requires so they could start selling their digital medicine on the U.S. soil. More to come, obviously.