Alexion submits BLA for long-acting C5 inhibitor for PNH

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) submitted a BLA to FDA for ALXN1210 to treat paroxysmal nocturnal hemoglobinuria (PNH) using a rare disease Priority Review voucher.

The submission is based on data from the Phase III ALXN1210-PNH-301 and ALXN1210-PNH-302 trials, each of which met its primary endpoint (see “Alexion’s Long-Acting C5 Inhibitor Meets in Phase III” and “Alexion's long-acting C5 inhibitor meets in Phase III switch trial”)...