BOGOTA, Colombia--(BUSINESS WIRE)--Pint Pharma is pleased to announce that the Colombian National Food and Drug Surveillance Institute (INVIMA) has approved ORLADEYO®, indicated for the prophylaxis of hereditary angioedema (HAE) attacks in patients 12 years of age and older. This milestone represents a significant advancement in expanding access to innovative treatment options for individuals living with HAE across Latin America.
“Today’s approval marks another important step in our mission to support patients living with rare diseases throughout Latin America,” said David Muñoz, CEO of Pint Pharma. “Beyond its direct clinical benefits, the availability of ORLADEYO® in Colombia reflects our ongoing commitment to advancing research and innovation in rare disease treatment.”
“The approval of ORLADEYO® by INVIMA is excellent news for the hereditary angioedema patient community in Colombia,” added Dr. Valnei Canutti, Hematologist and Chief of Scientific Affairs at Pint Pharma. “This innovative oral therapy represents a major breakthrough, offering an effective and convenient long-term prophylactic option for preventing HAE attacks.”
Mauricio Botero, General Manager of Pint Pharma in Colombia, concluded: “This approval is a significant achievement for patients and highlights the strong collaboration between the medical community, the regulatory authorities and the pharmaceutical industry in Colombia to improve treatment options for rare conditions like HAE.”
Hereditary angioedema is a rare genetic disorder characterized by recurrent episodes of painful and potentially life-threatening swelling of the skin, mucous membranes and internal organs. Until recently, treatment options for HAE were limited, significantly impacting patients’ quality of life and exposing them to the constant risk of unpredictable attacks.
About ORLADEYO® (berotralstat)
ORLADEYO® is the first and only oral therapy specifically developed to prevent hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 and older. Taken once daily, ORLADEYO® works by reducing plasma kallikrein activity, thereby preventing HAE attacks. ORLADEYO® is a product of BioCryst Pharmaceuticals, Inc., with registration, commercialization and distribution in Latin America exclusively managed by Pint Pharma.
About Pint Pharma
Pint Pharma is a specialty pharmaceutical company headquartered in Vienna, Austria, focused on acquiring, licensing and commercializing pharmaceutical products across Latin America. We are a community-driven organization committed to delivering innovative treatments and healthcare solutions through strategic partnerships with global leaders. Our mission is to ensure access, quality and excellence in care for patients across the region.
Contacts
Jorge Camacho
Chief Strategy Officer
e-mail: jorge.camacho@pint-pharma.com
Valnei Canutti
Chief of Scientific Affairs
e-mail: valnei.canutti@pint-pharma.com