MEXICO CITY--(BUSINESS WIRE)--It is with great pleasure that we announce the Federal Commission for Protection against Health Risks (COFEPRIS) in Mexico has granted approval for oral, once-daily ORLADEYO® (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age or older.
Hereditary angioedema is a genetic disorder that causes recurrent episodes of sudden and painful swelling of the skin, mucous membranes and submucosal tissues. Until recently, treatment options for HAE were limited, and patients faced the constant risk of severe attacks and compromised quality of life.
"The approval of Orladeyo by COFEPRIS is excellent news for the hereditary angioedema patient community in Mexico," comments Dr. Valnei Canutti, Chief Scientific Officer at Pint Pharma. "This innovative ORAL therapy represents a breakthrough for those living with this rare condition, offering an effective and convenient long-term prophylaxis option, preventing hereditary angioedema attacks."
According to David Munoz, CEO of Pint Pharma, "In addition to providing direct benefits to patients, the availability of Orladeyo in Mexico highlights our continued commitment to advancing research and innovation in the field of rare disease healthcare."
"The approval of Orladeyo is a great achievement for patients, and proof of the successful collaboration between the medical community, regulators, and pharmaceutical companies in Mexico to provide new treatment options," expressed Mauricio Botero, General Manager of Pint Pharma in LatAm North Cluster.
About Orladeyo
ORLADEYO® (berotralstat) is the first and only oral therapy specifically designed to prevent hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 and older. One ORLADEYO capsule per day prevents HAE attacks by reducing plasma kallikrein activity. ORLADEYO is a product of BioCryst Pharmaceuticals, Inc., and its registration, commercialization and distribution are exclusively handled by Pint Pharma in Latin America.
About Pint Pharma
Pint Pharma, headquartered in Vienna, Austria, is a specialty pharmaceutical company focused on acquiring or licensing, and commercializing pharmaceutical products for Latin America. We are a community-centered company and pride ourselves on providing exceptional expertise and know-how from the Latin American pharmaceutical industry, striving to deliver the best treatment and service to the population through strategic alliances with our global business partners.
