Horizon Therapeutics announced that its strategic partner Mitsubishi Tanabe Pharma Corporation (MTPC) has received manufacturing and marketing approval of Uplinza for the prevention of relapses of neuromyelitis optica spectrum disorder (including neuromyelitis optica) from the Japanese Ministry of Health, Labour and Welfare.
MTPC has rights to the development and commercialization of Uplinza for NMOSD as well as other potential future indications in Japan, Thailand, South Korea, Indonesia, Vietnam, Malaysia, Philippines, Singapore and Taiwan. Horizon is eligible to receive milestone payments based on certain milestones, plus payments based, in part, on sales revenue.
“The Uplinza approval in Japan is a significant milestone for NMOSD patients as it provides another treatment option for this devastating disease,” Tim Walbert, chairman, president and chief executive officer, Horizon, said in a company news release. “We continue to aggressively execute on a global expansion strategy with our other on-market and investigational medicines with the goal of bringing important treatments to those impacted by rare, autoimmune and severe inflammatory diseases.”
NMOSD is a rare, severe, autoimmune disease that attacks the optic nerve, spinal cord and brain stem, which leads to loss of vision and paralysis. In Japan, it has a low prevalence rate of 2 to 4 cases per 100,000 population1. The disease is primarily associated with anti-aquaporin 4 (AQP4) antibodies, which are detected in approximately 73%-90% of patients with NMOSD2.
In the United States, Uplinza is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.