CSL Behring announced the availability of Haegarda (C1 esterase inhibitor subcutaneous [human]) for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in adults and adolescents.
Haegarda was initially approved in June 2017, making it the first and only subcutaneous preventive treatment option for HAE in the U.S. In clinical trials, Haegarda reduced the number of HAE attacks by a median of 95% vs. placebo. Also, the use of Haegarda decreased the need for rescue medication by a median of >99% vs. placebo.
Haegarda works by replacing the missing or malfunctioning C1 esterase inhibitor protein in patients with HAE by restoring functional levels to >40% of normal. It has been postulated that increased vascular permeability and the clinical manifestation of HAE attacks may be primarily mediated through contact system activation. Suppression by the C1 esterase inhibitor through the inactivation of plasma kallikrein and factor XIIa is thought to modulate this vascular permeability by preventing the generation of bradykinin.
Haegarda has been granted 7 years of orphan-drug exclusivity by the Food and Drug Administration. It is available as a lyophilized powder in single-use vials containing 2000 or 3000 International Units (IU).
For more information call (866) 915-6958 or visit Haegarda.com.