FDA Grants Marketing Clearance to Propeller Platform for Use with GSK’s Breo Ellipta Inhaler
Propeller Health recently announced that its Propeller platform has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for use with Breo Ellipta, GSK’s dry powder inhaler.
On Dec. 1, 2015, Propeller, based in Madison, Wisconsin, and GlaxoSmithKline, headquartered in London, entered into a research and development agreement that led to the creation of the sensor for Breo Ellipta.
“We are pleased to announce the FDA clearance of the Propeller platform for use with GSK’s Ellipta inhaler,” David Van Sickle, Propeller’s co-founder and CEO, said in a press release. “Inclusion of GSK’s Ellipta inhaler in Propeller’s digitally-guided therapy platform is an important step in our goal of modernizing the management of respiratory disease.”
Van Sickle said Propeller will be working closely with GSK to deploy sensors for the Ellipta inhaler in the U.S. and overseas.
So far, the Propeller platform has been used by patients with chronic obstructive pulmonary disease (COPD) and asthma in 45 commercial programs nationwide, including major healthcare systems, payers, employers and other commercial partners.
Propeller aims to help patients and their physicians improve COPD and asthma standard of care as well as improve the symptoms and outcomes of these chronic diseases.
The FDA clearance follows CE Mark and Health Canada registration for the Propeller platform and system earlier this year, and marks the eighth time the FDA has cleared a Propeller product nationally and internationally.
Breo Ellipta inhalation powder contains a combination of fluticasone (a steroid) and vilanterol (a bronchodilator). It prevents the release of substances in the body that cause inflammation and relaxes the muscles in the airways in order to improve breathing. Breo Ellipta is to be used once-daily by COPD and asthma patients to help improve symptoms and prevent bronchospasm or asthma attacks.
In COPD patients, Breo Ellipta is indicated for long-term treatment. For asthma patients, the inhaler is a short-term therapy until symptoms are controlled with other medicines.
“While it is still in the early stages of development, the emerging field of digital healthcare holds great promise for respiratory medicine,” said Dave Allen, head of respiratory research and development at GSK. “The approval of the Propeller platform for use with the Ellipta inhaler will help us understand how patients interact with the Ellipta inhaler accurately and in real-time.”
“By exploring the benefits of sensor technology in this way, 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 trial,” Allen added.
The FDA’s 510(k) clearance permits the company to market the device using the 501(k) pathway, which allows the FDA to determine whether the product is equivalent to other products before marketing approval. Medical device manufacturers are required to submit a pre-market notification if they intend to introduce a device into commercial distribution for the first time, or reintroduce a device that will be significantly changed or altered.