FDA Orphan-Drug Exclusivity for HAEGARDA

The U.S. Food and Drug Administration (FDA) has granted CSL Behring seven years of orphan-drug exclusivity for HAEGARDA (C1 Esterase Inhibitor Subcutaneous [Human]), the first and only subcutaneous treatment option for prevention of HAE attacks. HAEGARDA was approved by the FDA on 22 June 2017 for routine prophylaxis to prevent HAE attacks in adolescent and adult patients, and marketing exclusivity will continue through 22 June 2024.

“HAEGARDA represents an important advance in the care of HAE, having been shown to reduce the number of HAE attacks by a median of 95 percent relative to placebo with subcutaneous delivery,” said Bill Campbell, Senior Vice President and General Manager, North America, CSL Behring. “CSL Behring is dedicated to delivering innovative products for rare diseases, including HAE, and we are pleased the FDA has recognized our commitment to helping positively impact the lives of patients with this debilitating and potentially life-threatening condition.”

HAEGARDA is a plasma-derived concentrate of C1-INH that is self-administered twice weekly subcutaneously. Subcutaneous administration of C1-INH builds and maintains a steady-state level of functional C1-INH activity and offers patients ease of use by eliminating the need for venous access, including ports. In addition, HAEGARDA had a reduction in the use of rescue medication by a median of greater than 99 percent relative to placebo.

To support access to HAEGARDA, CSL Behring offers HAEGARDA ConnectSM, a comprehensive support program providing a range of resources and programs to assist with HAE and HAEGARDA education and information, financial assistance programs, nursing services, and reimbursement support.

(Source: CSL Behring)

2017-07-22T03:26:39+01:00July 22, 2017|HAEi News|