FDA Grants Priority Review Status To New Indication for Alexion’s Soliris

The Food and Drug Administration granted priority review status to a supplemental biologics license application for Soliris (eculizumab), the drug’s manufacturer, Alexion Pharmaceuticals Inc., announced June 1.

Soliris is a biologic product that currently is approved by FDA for treating paroxysmal nocturnal hemoglobinuria (PNH). That approval came in 2007 (5 PLIR 307, 3/23/07).

Alexion submitted its supplemental biologics license application (sBLA), seeking approval for using Soliris to treat patients who have atypical hemolytic uremic syndrome (aHUS), a rare disease characterized by thrombotic microangiopathy (TMA), the formation of clots in small blood vessels throughout the body.

According to FDA ...