The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved garadacimab (brand name Andembry) for patients aged 12 years and older with hereditary angioedema (HAE) to prevent angioedema attacks.
The marketing authorization was granted to CSL Behring GmbH, a subsidiary of leading Australian biotech CSL Limited. This product was submitted and approved via a national procedure and ACCESS.
The MHRA noted study was undertaken with patients involving 64 adult and pediatric patients with HAE, who experienced at least who experienced at least 2 attacks during the run-in period, which lasted up to two months.
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