FDA Approves New BERINERT® (C1 Esterase Inhibitor, Human (Intravenous)) Administration Kit for Increased Patient Convenience
KING OF PRUSSIA, Pa., Aug. 3, 2021 -- 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.
BERINERT is a plasma-derived C1 Esterase Inhibitor (Human) indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) attacks in adult and pediatric patients. The safety and efficacy of BERINERT in preventing HAE attacks have not been established.
CSL Behring has marketed its C1 Esterase Inhibitor concentrate, BERINERT, in Germany for more than 30 years. The product is also approved and marketed in more than 20 European countries, the United States, Argentina, Australia, Canada, Israel, Japan and South Korea.
Important Safety Information
BERINERT®, C1 Esterase Inhibitor (Human), is contraindicated in individuals with a history of life-threatening systemic reactions to C1 esterase inhibitor preparations (including anaphylaxis).
Monitor patients for early signs of allergic or hypersensitivity reactions (including hives, generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis). If hypersensitivity is suspected, immediately discontinue administration of BERINERT and initiate appropriate treatment. Epinephrine should be immediately available for treatment of acute severe hypersensitivity reactions.
Serious arterial and venous thromboembolic (TE) events have been reported following administration of recommended doses of C1 Esterase Inhibitor (Human) products to patients with HAE. Risk factors may include presence of an indwelling venous catheter/access device; prior history of thrombosis; underlying atherosclerosis; use of oral contraceptives or certain androgens; morbid obesity; and immobility. Weigh benefits/risks before administering to patients with known risk factors for TE events and closely monitor such patients during and after BERINERT administration. TE events also have been reported with C1 Esterase Inhibitor (Human) products when used for unapproved indications at higher than recommended doses.
Appropriately trained patients may self-administer BERINERT upon recognition of an HAE attack. Advise patients to seek medical attention immediately following self-administration for laryngeal attacks, and to seek medical attention if progress of any attack makes them unable to properly prepare or administer dose of BERINERT.
BERINERT is derived from human plasma. The risk of transmission of infectious agents, including viruses and theoretically, the agents of Creutzfeldt-Jakob Disease (CJD) and its variant form (vCJD), cannot be completely eliminated.
The most serious adverse reaction reported in subjects who received BERINERT in clinical studies was an increase in severity of pain associated with HAE. Dysgeusia was the most common adverse reaction reported in over 4% of subjects and more frequently than in the placebo group.
BERINERT has not been evaluated in pregnant women or nursing mothers, and should be used only if clearly needed. In clinical trials, the half-life of BERINERT was shorter and clearance was faster in children than in adults; the clinical implication of this difference is not known.
Please see full prescribing information for BERINERT at http://www.BERINERT.com/prescribing-information.aspx
To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, the company develops and delivers innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 27,000 people worldwide, and delivers its life-saving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit Vita at CSLBehring.com/vita and follow us on Twitter.com/CSLBehring.
SOURCE CSL Behring