FDA Accepts Application for Subcutaneous Prophylactic Therapy

The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for CSL Behring’s low-volume subcutaneous (SC) C1-Esterase Inhibitor (C1-INH) Human replacement therapy, CSL830, as prophylaxis to prevent HAE attacks.

“The review of this application is another step towards providing advanced prophylactic treatment options to people living with HAE,” said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited. “Since we first reported the possibility of C1-INH replacement therapy for HAE over 40 years ago, we have remained committed to innovative research and providing advanced treatment options to people living with HAE. Subcutaneous prophylaxis is the next important step in helping HAE patients to prevent HAE attacks.”
(Source: CSL Behring)

2016-08-31T00:32:02+00:00