CSL Behring files HAE drug with FDA

CSL Behring, the US protein biotherapeutics-focused subsidiary of Australia's CSL group, says it has submitted a Biologics License Application to the Food and Drug Administration seeking approval to market its C1-esterase inhibitor for the treatment of hereditary angioedema. Specifically, the BLA requests clearance for the product as a therapy for patients suffering from acute attacks.

CSL said that the submission is based on data from the Phase II/III IMPACT trial, which recruited 124 HAE patients suffering from acute, moderate or severe facial or abdominal attacks. The results showed that the product, a pasteurized C1 inhibiting concentrate, was a safe and effective treatment for HAE, in terms of improving the time-to-onset of symptom relief.

At present, there are no specifically-approved therapies for the condition, which is thought to affect between 6,000 and 10,000 people in the USA.