Pharming Group has 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 in 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 years.

Leverne Marsh, Chief Commercial Officer, Pharming, said, “This launch is an important milestone in Pharming’s global expansion and underscores our commitment to bringing innovative medicines to rare disease communities worldwide. 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, Labor and Welfare (MHLW) in March this year as the first treatment specifically for APDS.

Under an agreement with Pharming, OrphanPacific, Inc. serves as the Marketing Authorisation (MA) 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.