The oral medication is intended for use in patients over the age of 12 years to prevent hereditary angioedema. Credit: LeviaUA/ Shutterstock.com.

Pint Pharma has announced that Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) has granted approval for Orladeyo (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks.

This marks a significant milestone for patients over the age of 12 years, providing a new oral once-a-day treatment option to prevent HAE.

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A rare genetic disorder, HAE is characterised by sudden episodes of swelling of the skin.

The approval of Orladeyo offers hope for improved quality of life for those affected by the condition.

BioCryst Pharmaceuticals’s Orladeyo is designed to prevent HAE attacks by hindering plasma kallikrein activity. It can significantly reduce the frequency of attacks.

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Pint Pharma is responsible for registering, marketing and distributing Orladeyo in Latin America.

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Pint Pharma chief scientific officer Dr Valnei Canutti stated: “The approval of Orladeyo by COFEPRIS is excellent news for the hereditary angioedema patient community in Mexico.

“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 latest development comes after the Brazilian Health Regulatory Agency (ANVISA) approved the medication for the same indication in the country.

In June 2023, Pint Pharma was chosen by PharmaEssentia as the commercial partner for BESREMi (ropeginterferon alfa-2b-NJFT) in Latin America.

Pint has an exclusive licence agreement to register and promote BESREMi for the treatment of polycythemia vera, a rare blood cancer, in Latin American countries, including Ecuador, Chile, Mexico, Argentina and Brazil.