Operational updates
Pharming submits a Marketing Authorisation Application to the European Medicines Agency for Leniolisib
Pharming Group N.V. announces that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, as a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, in adults and adolescents 12 years or older.
"This MAA submission, under an accelerated regulatory pathway, is an important step towards approval of our second product in the EEA and highlights Pharming’s ongoing commitment to advancing leniolisib as a treatment for patients with APDS."
- Anurag Relan | Chief Medical Officer