Pediatric Treatment for Hereditary Angioedema Gets FDA Approval
CSL Behring announced that the Food and Drug Administration (FDA) has approved the use of Berinert (C1 esterase inhibitor [human]) for the treatment of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in pediatric patients, in addition to adult patients.
This expanded approval makes Berinert the first approved HAE treatment for patients <12 years old. Also, the FDA has approved an update to the Geriatric Use section of the drug labeling. It states that the safety profile seen in the geriatric population was similar to that observed in the younger populations studied.
Berinert is a plasma-derived C1 esterase inhibitor (human). HAE patients have low levels of endogenous or functional C1 esterase inhibitor. Although the events that induce attacks of angioedema in HAE patients are not well defined, it has been postulated that increased vascular permeability and the clinical manifestation of HAE attacks may be primarily mediated through contact system activation. Suppression of contact system activation by 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.
Berinert is available as a 500 IU lyophilized concentrate in a single-use vial for reconstitution.
For more information call (866) 915-6958 or visit Berinert.com.