UPDATED: Propeller Health gets FDA nod to sell app, sensor with GSK inhalers

Propeller Health's mobile platform--Courtesy of Propeller Health

Smart inhaler company Propeller Health received FDA clearance to sell its sensor and digital health platform in association with GlaxoSmithKline's ($GSK) Diskus dry powder inhaler for asthma and COPD.

The device and associated technology is also cleared for use with Boehringer Ingelheim's Respimat inhaler for COPD. The clearance for that was obtained in March, but Propeller just publicized it for the first time, COO Chris Hogg told FierceMedicalDevices in an interview.

The company previously revealed that was it developing the sensor for the Respimat in collaboration with BI. Hogg said it developed the Diskus sensor independently of GSK.  

Propeller previously had FDA clearance to market the device to patients with chronic respiratory disease who use a pressurized metered-dose inhaler.

According to a company release, the Propeller System now has FDA permission to market claims to "increase adherence to therapy, predict oncoming exacerbations and help reduce the frequency of symptoms and exacerbations in asthma and COPD."

Hogg said the permission was granted after the company shared data with the FDA from a soon to be published 500- person randomized trial, a 125-person study and its 35 commercial programs. He is not aware of another company permitted to make similar claims.

Propeller will continue to sell its device in partnership with doctors and insurance companies. The product is available by prescription only.  

The digital health system is available over Apple and Android smartphones, as well as tablets and personal computers.

During a prior interview, Propeller COO Chris Hogg elaborated on the company's technology. Based on data collected from the sensor, which attaches to the inhaler, the system's mobile app gives personalized advice and coaching, telling patients things such as: "Looks like you've been forgetting to take the inhaler more on Monday morning," he said. It also reminds patients to use their inhaler and alerts physicians when there is an uptick in use of the rescue inhaler for sudden asthma attacks, as opposed to the inhaler for regular use. Information is collected in a "passive" manner so the patient and caregiver don't have to perform extra work in order to benefit from the sensor.

A new feature permitted by the clearance is the use of audio and visual reminders to take the medication that are located on the device itself, Hogg said. He added that monitoring technique is harder than tracking usage, though Propeller is working on adding technology to the sensor that can help it track how much of the medication was actually inhaled.

CVS Health ($CVS) CEO Larry Merlo has said that medication nonadherence is costing the healthcare system about $300 billion per year in unnecessary costs.

"Poor adherence to inhaled medications remains a common barrier to successful management of respiratory disease," said Dr. David Mannino, a professor of medicine at the University of Kentucky, in a statement. "Propeller has demonstrated that engagement with their platform can change this, doubling adherence and providing significant clinical benefit. I'm encouraged by the potential of combining digital services with existing therapies to improve outcomes. Adding these important medications to Propeller's system will help improve care for many patients with COPD and asthma across the US."

Adding the Diskus franchise of inhalers expands Propeller's addressable market by about 14 million prescriptions representing 54.5% of the combination inhaled corticosteroid/long-acting beta agonist product market, based on 2014 data.

Hogg said the company hopes to make sensors for GSK's Ellipta inhaler franchise as well, saying "we believe that every sensor should be made specifically for each form factor."

- here's the release

FierceDrugDelivery's 10 biggest partnerships in drug delivery - Boehringer Ingelheim- Propeller Health

Editor's Note: This article has been updated with new information from the company's COO.