GlobeNewswire·Aug 13, 2026, 1:00 AM ET

Pharming announces commercial launch of Joenja (leniolisib) in Japan for adult and pediatric patients with APDS aged 4 and older

Pharming Group announced the commercial launch of Joenja (leniolisib) in Japan for adult & pediatric patients aged 4 years and older with activated PI3K delta syndrome (APDS).
Japan is the first global market to commercially offer Joenja for children aged 4 to 11 following inclusion on the Japan National Health Insurance drug price list.
OrphanPacific, Inc. serves as the Marketing Authorization Holder for Joenja in Japan & is responsible for supply & distribution under an agreement with Pharming.
The launch follows approval by Japan's Ministry of Health, Labour & Welfare (MHLW) in March 2026 as the first specific treatment for APDS.
Joenja is currently approved in the U.S., U.K., EU, Australia, Israel, Canada, South Korea, & Saudi Arabia for patients aged 12 years & older.
APDS is a rare primary immunodeficiency caused by variants in PIK3CD or PIK3R1 genes, characterized by immune dysregulation, recurrent infections, & a median diagnostic delay of 7 years.
Clinical trials demonstrated that Joenja statistically significantly improved immune dysregulation & deficiency endpoints, with long-term safety data supporting its use.
Leniolisib remains under regulatory review for pediatric patients in several countries & is being evaluated in Phase II trials for other primary immunodeficiencies beyond APDS.