FDA clears digital sensor for GSK inhaler
pharmafile | November 8, 2016 | News story | Manufacturing and Production, Sales and Marketing | FDA, GSK, GlaxoSmithKline, Propeller Health, ellipta
The FDA has given 510(k) clearance to a smart inhaler sensor developed by Propeller Health for use with GlaxoSmithKline’s Ellipta dry powder inhaler, marking the eighth international FDA clearance for the company.
The device features proprietary sensor technology and functions alongside a companion app which is designed to help patients and medical professionals to tackle asthma and chronic obstructive pulmonary disease (COPD) by gathering data from a range of services and sources remotely, using “machine intelligence” to generate personalised treatment recommendations. The platform has been utilised in more than 45 commercial programmes in the US such as healthcare systems, employers and payers.
Dave Allen, GSK’s head of respiratory R&D, commented: “While it is still in the early stages of development, the emerging field of digital healthcare holds great promise for respiratory medicine.” Allen noted that the approval “will help us understand how patients interact with the Ellipta inhaler accurately and in real-time…we hope to gain valuable insights into usage patterns with the ultimate goal of driving improvements in patient care while reducing the complexity and cost of clinical trials.”
The newly-approved technology is the latest product of an R&D partnership forged by GSK and Propeller late last year to develop sensor tech for the pharma giant’s Ellipta product. Propeller CEO David van Sickle remarked: “Inclusion of GlaxoSmithKline’s Ellipta inhaler in Propeller’s digitally-guided therapy platform is an important step in our goal of modernising the management of respiratory disease. We look forward to working closely with GlaxoSmithKline to deploy sensors for the Ellipta inhaler in the US and abroad, in the near term.”
Matt Fellows
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