Pharming gets Joenja marketing authorization in UK
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja (leniolisib), from Netherlands-based Pharming (Euronext: PHARM), for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.
Pharming’s shares rose almost 5% to 0.73 euros on the news.
Leniolisib, an oral, selective PI3Kδ inhibitor, is the first treatment approved in the U.K. specifically for APDS, a rare and progressive primary immunodeficiency. Leniolisib is currently under evaluation by health technology assessor the National Institute for Health and Care Excellence (NICE) regarding reimbursement within the National Health Service (NHS) in England.
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