Baxter International (Deerfield, IL) is developing a system to produce sterile solutions for peritoneal dialysis (PD) in patients’ homes. The company said it received FDA guidance about the regulatory pathway for the system, which would be integrated into Baxter’s Amia PD System with a small water-filtration device.
Baxter notes that the system for PD solutions plus the Amia PD system would be considered a combination product and was placed in the specific regulatory approval pathway the FDA uses when a product comprises a device plus a pharmaceutical product.
Baxter plans to begin a clinical trial in 2018, with regulatory submission to the FDA sometime in 2019. Laura Angelini, general manager of Baxter’s Chronic Renal business, said, “These technology advancements have the potential to greatly enhance home dialysis therapy for patients by providing solution generation on-demand.”
The Amia system is currently in about 1700 US homes where patients undertake home dialysis, and the system has provided a total of 250,000 dialysis treatments. The Amia system integrates with a telehealth platform called SHARESOURCE, allowing health care providers to manage patients remotely. With the addition of a pharmaceutical system for on-demand PD solution, physicians would have the flexibility to prescribe different dextrose concentrations as needed for each cycle that the solution dwells in the cavity before draining, usually three or four times, depending on a patient’s needs, Baxter said.
The home solution system would reduce storage and weight handling requirements that come with traditional PD therapy. Patients typically must have space to store approximately a one-month supply of PD solutions—up to 40 boxes. Each box of PD solution weighs approximately 30 pounds and can be burdensome for patients and care givers.
In other Baxter news, the company recently partnered with Mayo Clinic, headquartered in Rochester, MN, in a five-year research and development partnership that will begin with a focus on kidney disease.
“We are excited about combining Mayo’s clinical and research expertise with Baxter’s ability to apply scale and innovation,” Gianrico Farrugia, vice president of Mayo Clinic and CEO of Mayo Clinic in Florida, said in a statement. “We are confident that this collaboration will help accelerate discoveries, development, and application of life-changing therapies for patients.” The agreement includes a five-year renewal option and the work will be performed in Mayo’s Florida clinic in Jacksonville.
