Pharming launches Joenja in Japan for APDS patients

• Pharming launched Joenja (leniolisib) in Japan for adult and pediatric patients aged 4 years and older with activated PI3K delta syndrome (APDS).
• Japan becomes the first commercial market where Joenja is available for children aged 4 to 11 following inclusion on the national health insurance drug price list.
• Pharming is expanding Joenja availability through its partnership with OrphanPacific, which manages marketing authorization, supply, and distribution in Japan.

Pharming (NASDAQ:PHAR) announced the commercial launch of Joenja (leniolisib) in Japan for patients aged 4 years and older with activated PI3K delta syndrome (APDS), following its inclusion on Japan’s National Health Insurance drug price list.

The launch follows approval from Japan’s Ministry of Health, Labour and Welfare in March, making Joenja the first treatment specifically approved for APDS in Japan.

Under the agreement, OrphanPacific serves as the Marketing Authorization Holder in Japan and, together with Pharming, is responsible for supplying and distributing Joenja to eligible patients.

Pharming said Japan is the first market where Joenja is commercially available for pediatric patients between 4 and 11 years old, expanding access beyond adult APDS patients.

Pharming developed Joenja as a treatment targeting APDS, a rare immune disorder caused by changes affecting the PI3K delta pathway, and has continued commercial expansion following approvals in multiple regions.

The company is using partnerships with regional pharmaceutical providers, including OrphanPacific in Japan, to support availability and distribution of Joenja in additional markets.