The US Food and Drug Administration (FDA) has granted priority review to Alexion's (Nasdaq: ALXN) ALXN1210, a long-acting C5 complement inhibitor, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
This designation will see the drug's total review process expedited, now set to finish four months early in February 2019, when it could become the successor in PNH to Alexion's own Soliris (eculizumab).
"We are working with the FDA to facilitate a smooth review," said John Orloff, executive vice president and R&D head at Alexion.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze