Berotralstat: A Review of Hereditary Angioedema (Review Article)

Author(s): *Abhijit Shitole, Kajal Raut, Tejaswini Adsul, Snehal Durande, Amit Pondkule and Diksha Shinde

Abstract: Berotralstat or ORLADEYO (BCX7353) is a highly selective oral kallikrein inhibitor that was recently approved for the prevention of angioedema attacks in adults and children aged 12 and older with hereditary angioedema. Hereditary angioedema is a rare genetic disorder characterized by recurrent episodes of severe swelling of the limbs, face, intestinal tract, and airway caused by a lack of a C1 esterase inhibitor (C1-INH). Because laryngeal edema can be fatal due to asphyxiation, proper diagnosis and management of hereditary angioedema are critical. Self-administration of treatment is advised and has been linked to improved quality of life in patients with hereditary angioedema. There is a significant unmet need for HAE treatment options that are less invasive than the currently available targeted parenteral prophylactic therapies. This need could be met with an oral medication that is both effective and well tolerated, with a lower adverse effect profile than the current oral agents. The efficacy and safety of berotralstat were evaluated in a single, well-controlled, adequately designed pivotal trial in Type I and II HAE patients 12 years of age and older. ORLADEYO is available in hard gelatin capsules of 150 mg (equivalent to 169.4 mg berotralstat dihydrochloride) and 110 mg (equivalent to 124.2 mg berotralstat dihydrochloride) for oral administration.

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