Pint Pharma is pleased to announce that ORLADEYO® (berotralstat) has been approved by the General Directorate of Medicines, Supplies and Drugs (DIGEMID) in Peru for daily oral use in the prophylaxis of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older.
Hereditary angioedema is a genetic disorder characterized by recurrent episodes of sudden, painful swelling of the skin, mucous membranes, and submucosal tissues. Until recently, treatment options for HAE have been limited, significantly impacting patients’ quality of life and leaving them vulnerable to severe attacks.
“The approval of ORLADEYO by DIGEMID is excellent news for the hereditary angioedema community in Peru,” said Dr. Valnei Canutti, Chief Scientific Officer of Pint Pharma. “This innovative oral therapy represents a breakthrough for patients living with this rare condition, offering an effective and convenient long-term prophylaxis option to prevent HAE attacks.”
David Muñoz, CEO of Pint Pharma, emphasized, “Beyond the direct benefits to patients, the availability of ORLADEYO in Peru underscores our ongoing commitment to advancing research and innovation in healthcare for rare diseases.”
Mauricio Botero, General Manager of Pint Pharma in the Latam North Cluster, added, “The approval of ORLADEYO is a significant achievement, highlighting the successful collaboration between the medical community, regulators, and pharmaceutical companies in Peru to enhance treatment options.”
ORLADEYO® (berotralstat) is the first and only oral therapy designed to prevent HAE attacks in patients aged 12 years and older by reducing plasma kallikrein activity. Distributed exclusively by Pint Pharma in Latin America, ORLADEYO is a product of BioCryst Pharmaceuticals, Inc.
Headquartered in Vienna, Austria, Pint Pharma specializes in acquiring or licensing and marketing pharmaceutical products for Latin America. With a strong focus on community and strategic global partnerships, Pint Pharma strives to provide exceptional treatment and service to the Latin American population.