CSL Behring receives U.S. Food and Drug Administration (FDA) approval for its supplemental request for co-packaging of a convenience administration kit along with its product Berinert, indicated for the treatment of acute abdominal, facial, or laryngeal attacks of HAE in adult and pediatric patients. Combination product packaging will improve the patient experience by providing ready-to-go, essential infusion supplies that are more efficiently packaged. This will also reduce the burden and responsibility on distributing specialty pharmacies in supplying separate administration materials.
“HAE affects my life daily; with the concerns and stress of not only maintaining my own health as a patient, but also that of my child who also has HAE,” says Machelle, a person living with HAE. “Regardless of being on a preventive therapy or not, being prepared to rapidly treat an HAE attack is of utmost importance”.
Berinert is the only C1 esterase inhibitor (C1-INH) approved to treat acute abdominal, facial, or laryngeal HAE attacks in adults and pediatric patients. In accordance with the World Allergy Organization Guidelines for the Management of HAE, it is recommended that all patients have sufficient medication for on-demand treatment of two attacks and carry on-demand medication at all times.
Combination product packaging will now include a 10 mL silicone-free syringe as well as an IV set and butterfly needle and is anticipated to be in-market within the third quarter of 2021.
(Source: CSL Behring)
