• Launch marks first commercial availability of Joenja® (leniolisib) for children aged 4 to 11 worldwide
• OrphanPacific, Inc. serves as Marketing Authorization holder and is responsible for supply and distribution in Japan

Pharming Group  announced the commercial launch of Joenja (leniolisib) in Japan for adult and pediatric patients with activated PI3K delta syndrome (APDS) aged 4 years and older, following its inclusion on the Japan National Health Insurance (NHI) drug price list. With this launch, Japan is now the first market where Joenja is commercially available for children aged 4 to 11.

“This launch is an important milestone in Pharming’s global expansion and underscores our commitment to bringing innovative medicines to rare disease communities worldwide,” said Leverne Marsh, Chief Commercial Officer of Pharming. “For eligible patients and their families in Japan, who until now have had limited treatment options beyond supportive care, this launch represents meaningful progress in addressing a significant unmet need. We are grateful to OrphanPacific for its partnership and close collaboration in helping make this treatment available.”

The launch of Joenja in Japan follows its approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) in March of this year as the first treatment specifically for APDS. Under an agreement with Pharming, OrphanPacific, Inc. serves as the Marketing Authorization Holder for Joenja in Japan and in collaboration with Pharming, is responsible for supply and distribution of the product.

Joenja® is a registered trademark owned by Pharming Group N.V. or its affiliates.