Sensor on GSK’s Ellipta inhaler connected to Propeller Health’s monitoring platform.
Propeller Health has earned U.S. Food and Drug Administration 510(k) clearance to sell its therapy platform with a newly developed sensor that works with GlaxoSmithKline’s Ellipta inhaler. The Madison, Wisconsin-based digital health company had announced a development pact with GSK on Dec. 1, 2015, so the two partners designed, built and got clearance for the sensor in less than a year.
This is the eighth FDA clearance Propeller Health has received for its respiratory therapy platform. Propeller had previously earned the CE Mark in Europe and approval by Health Canada to sell the platform and sensor for Ellipta, a next-generation, patented dry-powder inhaler for respiratory ailments.
Propeller’s clearances are all for treatment of asthma and chronic obstructive respiratory disease. The latest FDA nod has “no major difference” in terms of marketing scope, Propeller Health CEO and co-founder David Van Sickle said.
“It’s connecting this new franchise [Ellipta] to the Propeller system” that is different about the latest clearance, Van Sickle explained. Propeller sensors mounted on inhalers record when patients take their asthma or COPD prescriptions to help improve medication adherence and predict flare-ups that could necessitate emergency care.
“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,” GSK R&D chief Dave Allen said in a press release issued early Monday morning. “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 trials,” Allen explained.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Van Sickle declined to say when Ellipta inhalers with the Propeller system would hit the market in the U.S. That announcement likely would come from GSK, he noted.
Van Sickle also would not comment on any other products Propeller Health and GSK might be working on together.
In an email interview with MedCity News last month, Van Sickle did say Propeller expect to expand its platform to support additional respiratory drugs by next year. “We’ll continue to increase the amount and type of data we gather, too, and use that information to help patient-physician teams identify and apply the right treatment and approach for a given individual,” he said then.
Photo: Propeller Health
