India, May 23 -- Pharming Group (PHAR) announced that the European Commission granted marketing authorization for Joenja (leniolisib), an oral, selective phosphoinositide 3-kinase (PI3K) delta inhibitor, for the treatment of activated PI3K delta syndrome (APDS), a rare primary immunodeficiency, in adult and pediatric patients 12 years of age and older.
Joenja is the first and only approved treatment for APDS in the European Union (EU). The first European launch is expected in Germany in third quarter of 2026, with additional launches anticipated pending completion of national reimbursement negotiations.
The approval is valid across all 27 EU Member States, as well as Norway, Iceland and Liechtenstein. Joenja is currently marketed in the U...