FDA backs BLA for Traumakine in orphan disease

Traumakine’s (recombinant human interferon beta-1a) chances of becoming the first approved pharmacological treatment for acute respiratory distress syndrome (ARDS) have been boosted by news that the US Food and Drug Administration (FDA) has proposed that it proceeds directly to a Biologics License Application (BLA) submission pending positive trial results.

The ongoing Phase III trials are taking place in Europe and Japan, but the FDA is happy that as long as it is satisfied with the resulting data, a BLA can be filed despite it coming from studies being conducted outside the USA.

"This brings us one step closer to delivering Traumakine to patients in the world’s largest pharmaceutical market"