As of 24 March 2017, Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an extended use of Berinert from CSL Behring, a C1-esterase inhibitor (C1-INH) concentrate, for pre-procedure prevention (short-term prophylaxis) of acute episodes of HAE .
Berinert is now indicated for the treatment of acute episodes and for pre-procedure prevention (short-term prophylaxis) of acute episodes of HAE. Berinert as the first and only C1-INH concentrate therapy in Japan has been used for acute episodes of HAE for many years.
This important approval supports further treatment options for the use of C1-INH concentrate as first-line therapy for the prevention of potentially life-threatening HAE attacks triggered by surgical or dental procedures.
Responding to reports of swelling of tongues or larynx triggered by surgical or dental procedures that may become fatal, the Japanese Society of Oral and Maxillofacial Surgeons and the Japanese Dermatological Association petitioned an extended use of C1-INH concentrate for short-term prophylaxis at pre-procedure prevention.
The petition has successfully been supported to apply Public Knowledge-based Application be submitted by “Review Committee on Unapproved Drugs and Indications with High Medical Needs” as to be an indication that can provide significant clinical benefits, and then concluded by the MHLW advisory committee as of November 2016 that efficacy and safety profiles of this product were already well-known medically pharmaceutically.
(Source: CSL Behring K.K.)