Phase III study of weekly subcutaneous (SC) ravulizumab for paroxysmal nocturnal haemoglobinuria (PNH) meets primary endpoint

Ongoing study met its primary objective of pharmacokinetic based non-inferiority of SC vs. IV infusion at day 71. Alexion expects to file for approval in US and EU for SC formulation and device combination in PNH and atypical haemolytic uremic syndrome in late 2021.

Source:

Biospace Inc.