The European Medicines Agency has agreed to fast-track Pharming Groups planned EU marketing authorization application (MAA) for leniolisib, making the investigational drug for treating the rare immunodeficiency, APDS, the first product to be granted an accelerated assessment by the regulator this year.
Accelerated Assessment Dry Spell Over As EMA Says Yes To Pharming’s Leniolisib
MAA Filing Is Planned In October
Leniolisib has become the first product to be granted accelerated assessment status by the European Medicines Agency this year.
