pacman schreef op 3 augustus 2021 15:26:
FDA Approves New BERINERT® (C1 Esterase Inhibitor, Human (Intravenous)) Administration Kit for Increased Patient Convenience
FDA keurt nieuwe BERINERT® (C1-esteraseremmer, humaan (intraveneus)) toedieningskit goed voor meer gemak voor de patiënt
CSL Behring, a global biotherapeutics leader received U.S. Food and Drug Administration (FDA) approval for its supplemental request (submitted Aug. 30, 2020) 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 hereditary angioedema (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 is a rare, genetic and potentially life-threatening condition that causes painful, potentially debilitating and unpredictable episodes of swelling of the abdomen, larynx, face and extremities, among other areas of the body. HAE is caused by deficient or dysfunctional C1-INH, a protein in the blood that helps to control swelling.
"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," said 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.