BioCentury
ARTICLE | Company News

Alexion sales and marketing update

June 9, 2014 7:00 AM UTC

Alexion recalled nine additional lots of Orphan drug Soliris eculizumab distributed in the U.S. due to the presence of visible particles. Alexion said there has not been any identifiable safety concern attributed to the lots. The company believes that it has identified the filling process step that resulted in the presence of the particles and implemented the change necessary to correct the issue. Alexion said the product was last shipped on Oct. 29, 2013, and thus the company believes there is little, if any, inventory being held at the hospital or user level. Alexion said that following this recall, there will no longer be Soliris in the U.S. manufactured using the identified process step. ...