ORLADEYO® (berotralstat) Approved in Peru

Core Viewpoint - BioCryst Pharmaceuticals has received approval from Peru's DIGEMID for ORLADEYO® (berotralstat) as a prophylactic treatment for hereditary angioedema (HAE) in patients aged 12 and older, marking a significant expansion in treatment options for HAE in the pan-Latin America region [1][2]. Group 1: Product Information - ORLADEYO® (berotralstat) is the first oral therapy specifically designed to prevent HAE attacks in adults and pediatric patients aged 12 years and older, with a recommended dosage of one capsule per day [3]. - The drug functions by decreasing the activity of plasma kallikrein, which is involved in the pathophysiology of HAE [3]. - ORLADEYO has already received regulatory approvals in Chile, Argentina, Brazil, and Mexico, indicating a growing acceptance in the Latin American market [2]. Group 2: Collaboration and Commercialization - BioCryst has an exclusive collaboration with Pint Pharma GmbH for the registration and promotion of ORLADEYO in the pan-Latin America region, with Pint responsible for obtaining and maintaining marketing authorizations [2]. - The partnership aims to enhance the availability of ORLADEYO for patients in need of new treatment options across Latin America [1]. Group 3: Safety and Efficacy - The safety and effectiveness of ORLADEYO for treating acute HAE attacks have not been established, and it is not recommended for such use [5]. - Common adverse reactions observed in patients taking ORLADEYO include abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease, with a noted increase in QT prolongation at dosages higher than 150 mg [6][5]. - A reduced dosage of 110 mg is recommended for patients with moderate or severe hepatic impairment [6]. Group 4: Company Overview - BioCryst Pharmaceuticals is a global biotechnology company focused on developing therapies for rare diseases, leveraging expertise in structure-guided drug design to create innovative treatments [8].