Innovation in Pharmaceuticals in the US: Digital Medicine-integrating your medicine with your mobile device.
November 2017: The United States Food and Drug Administration approved for the first time a Digital Medicine – Otsuka’s ABILIFY MYCITE®, embedded with Proteus’ ingestible sensor.
It is 35 years since the FDA has enabled a new category of drug product –the last time was a biologic in 1982. FDA has now opened a new regulatory pathway for innovation in pharmaceuticals based on silicon and software. “We think that is a very significant opportunity to create new therapies that improve outcomes and lower costs, leveraging the most ubiquitous computing platform we have ever seen – the mobile device in everyone’s pocket”- Andrew Thompson, Chief Executive Officer at Proteus Digital Health.
“We believe ABILIFY MYCITE can be a major advance in the care of individuals with schizophrenia, bipolar I disorder, or major depressive disorder, who take ABILIFY to treat their condition. The data on medication ingestion, activity, rest and mood created by this solution can be used by patients and their care teams to build more effective collaboration, ensure proper dosing and deliver peace of mind to family members.”