FDA declines to approve Proteus-Otsuka sensor-equipped pill

Shared by Radhika Narayanan | 0 414 2 | about 3 years ago

The FDA declined to approve what would have been the first mass market drug to incorporate Proteus Digital Health’s ingestible sensor. The drug, a collaboration between Proteus and Otsuka Pharmaceuticals, combines the Proteus system with the antipsychotic pharmaceutical Abilify.

“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.”

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