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news.Brazil's Health Regulatory Agency (ANVISA) has approved Orladeyo (berotralstat) for the prevention of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 and older, offering a new oral treatment for those suffering from this genetic disorder.
Brazil's Health Regulatory Agency (ANVISA) approves Orladeyo. Credit: Mustafa shehadeh from Pixabay.
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A product of BioCryst Pharmaceuticals, Orladeyo’s registration, commercialisation and distribution are solely handled by Pint Pharma in Latin America.
Hereditary angioedema (HAE) is a genetic disorder characterised by sudden, painful swelling of the skin, mucous membranes, and submucosal tissues.
Patients with HAE have historically had limited treatment options, impacting their quality of life and leaving them at risk of severe attacks.
Pint Pharma chief scientific officer Dr. Valnei Canutti said, “The approval of Orladeyo by ANVISA is excellent news for the hereditary angioedema patient community in Brazil. 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 (HAE) attacks.”
Pint Pharma CEO David Munoz said: “In addition to providing direct benefits to patients, the availability of Orladeyo in Brazil highlights our continued commitment to advancing research and innovation in the field of rare disease healthcare.”
Pint Pharma in Brazil general manager Fernanda Bertasi emphasised the collaborative effort behind the drug’s approval, saying, “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 Brazil to enhance the treatment options.”
Orladeyo is claimed to be the first and only oral therapy designed specifically to prevent HAE attacks in adult and pediatric patients aged 12 and older. It works by reducing plasma kallikrein activity, with just one capsule needed daily to prevent attacks.
Pint Pharma, headquartered in Vienna, Austria, specialises in acquiring, licensing, and commercialising pharmaceutical products in Latin America.
