Japan’s Ministry of Health, Labour and Welfare has approved Inspire Medical Systems Inc’s Inspire therapy to treat moderate to severe obstructive sleep apnea (OSA).
Inspire obtained CE Mark for its Inspire therapy in 2010 and US Food and Drug Administration approval in 2014. To date, physicians have treated more than 3,000 patients worldwide with Inspire therapy.
“With this approval for our Inspire therapy, we are able to provide patients and physicians in Japan with a new alternative for the treatment of moderate to severe OSA,” says Tim Herbert, president and CEO of Inspire Medical Systems, in a release. “Our Inspire therapy is supported by a strong body of evidence with more than 5 years of clinical experience demonstrating the efficacy and safety of our therapy for patients and physicians. We look forward to commercializing our Inspire therapy in Japan.”
Recent published data estimates that 9% of Japanese men and nearly 3% of Japanese women are diagnosed with OSA. Further reports indicate that approximately 9 million Japanese have an apnea hypopnea index (AHI) greater than 15, which qualifies them at least as moderate OSA patients. Inspire will now seek reimbursement coverage for its therapy in Japan. The reimbursement process will require significant time and interactions with the authorities in Japan. As a result, along with the planned organizational development and physician training, Inspire intends to launch its therapy in Japan in the second half of 2019.
Inspire will be discussing the clinical outcomes and patient experiences with Japanese physicians at the Japanese Society of Sleep Research and the Asian Sleep Research Society (ASRS) meetings, which will be jointly held in Sapporo, Japan, on July 11–13, 2018.
“We would like to thank Cobridge Co, Ltd. a leading regulatory affairs consulting firm that provides comprehensive product registration services for medical products in Japan, for their outstanding efforts and expertise in assisting us to gain approval in Japan,” Herbert says.
from Sleep Review http://www.sleepreviewmag.com/2018/06/inspire-therapy-gets-regulatory-approval-japan/