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  • FDA approves new Berinert administration kit

FDA approves new Berinert administration kit

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Published:11th Aug 2021
CSL Behring, a global biotherapeutics leader has received 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.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.

Condition: Hereditary Angio-Oedema
Type: drug

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