Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for leniolisib
Pharming Group N.V. announces today that its Marketing Authorisation Application (MAA) for leniolisib has been validated for scientific evaluation under an accelerated assessment by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).
Marketing authorisation for leniolisib in the European Economic Area is anticipated in H1 2023.
“EMA’s validation for review of our MAA under an accelerated assessment pathway highlights Pharming’s ongoing commitment to advance leniolisib as a targeted treatment for adults and adolescents 12 years of age or older with APDS."- Anurag Relan, MD, MPH | Chief Medical Officer