From www.cslbehring.com August 30, 2016 News, Press Release

FDA Accepts CSL Behring’s Biologics License Application for First Subcutaneous Prophylactic Therapy to Prevent Hereditary Angioedema Attacks

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for its low-volume subcutaneous (SC) C1-Esterase Inhibitor (C1-INH) Human replacement therapy, CSL830, as prophylaxis to prevent Hereditary Angioedema (HAE) attacks. HAE is a rare genetic disorder caused by a deficiency of C1-INH, one of the proteins that work with the body’s immune system to control inflammation. Symptoms of HAE include episodes of swelling in the face, abdomen, larynx and extremities and can be fatal if untreated.

“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 CSL Behring 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.”

Read full article


24_7_140


For HAE Emergency:

If you are having an HAE medical emergency, please hang up and dial 911 immediately. For non- emergencies please contact your HAE treating doctor.


For non-emergency questions
– contact a Patient Advocate:

(866) 798-5598

Take action

– and make a difference


  Join our family – become a member of HAEA

  Call our Patient Advocates

  Join the HAEA Café

  Get a referral to an HAE Physician

  Become an Advocate for HAEA

  Have your family checked for HAE

  Join our group on Social Media

  Participate in an event

Participate in our Scientific Registry

  Shop for merchandise

  Volunteer

  Share your HAE story