Daily Newsletter

10 July 2024

Daily Newsletter

10 July 2024

ORLADEYO gains approval in Peru for HAE prevention

The once-daily oral capsule prevents HAE attacks by inhibiting plasma kallikrein activity.

Archana Rani July 10 2024

Pint Pharma has announced the approval in Peru of Orladeyo (berotralstat) for use as an oral therapy to prevent hereditary angioedema (HAE) attacks.

Orladeyo is a product of BioCryst Pharmaceuticals. Pint Pharma owns its registration, marketing and distribution rights in Latin America (LATAM).

Approved by Peru's General Directorate of Medicines, Supplies and Drugs, it is intended for the prophylaxis of HAE attacks in adults and children aged 12 and above.

Hereditary angioedema is a genetic disorder. It results in recurrent episodes of painful swelling of the mucous membranes, skin and submucosal tissues.

Pint Pharma scientific director Dr Valnei Canutti stated: “The approval of Orladeyo by DIGEMID is excellent news for the community of patients with hereditary angioedema in Peru.

“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.”

The once-daily oral capsule has been primarily developed to prevent HAE attacks by inhibiting plasma kallikrein activity.

Pint Pharma CEO David Muñoz stated: “Besides providing direct benefits to patients, the availability of Orladeyo in Peru highlights our continuous commitment to the advancement of research and innovation in the field of medical care for rare diseases.”

Pint Pharma LATAM North Cluster general manager Mauricio Botero stated: “The approval of Orladeyo is a great achievement for patients and proof of the successful collaboration among the medical community, regulators, and pharmaceutical companies in Peru to improve treatment options.”

In 2023, BioCryst secured marketing authorisation from the Public Health Institute of Chile for ORLADEYO.

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