Orladeyo approved in Mexico for HAE patients ages 12 and older
Oral therapy is 1st OK’d in country for preventing HAE swelling attacks
Orladeyo (berotralstat), an oral therapy designed to prevent swelling attacks in adults and adolescents with hereditary angioedema (HAE), has now been approved in Mexico.
The approval by the Mexican Federal Commission for Protection against Health Risks (COFEPRIS) covers the use of Orladeyo as a prophylactic, or preventive, treatment for HAE attacks in patients ages 12 and older. With the approval, Orladeyo has now become the first oral prophylactic HAE therapy available in the country, according to Pint Pharma, which is the exclusive distributor of the medication in Latin America.
“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,” Mauricio Botero, general manager of Pint Pharma in LatAm North Cluster, said in a company press release.
Pint is the company responsible for leading the approval requests and commercialization of Orladeyo in Latin America, following an agreement established with BioCryst Pharmaceuticals, Orladeyo’s original developer, back in 2022.
The decision by COFEPRIS follows similar approvals in Brazil, Argentina, and Chile. The medication has been approved in the U.S. since 2020, and in the European Union since 2021.
Real-world data supports long-term effectiveness of Orladeyo
Headquartered in Austria, Pint is a specialty pharmaceutical company that focuses on getting medications to the market in Latin America.
“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,” said David Munoz, Pint Pharma’s CEO.
HAE is marked by sudden and recurrent swelling attacks affecting the deeper layers of the skin, the upper airways, and the gastrointestinal tract. The disease is caused by mutations that result in the excess production of a signaling molecule called bradykinin, which widens blood vessels and increases their permeability, causing fluid to leak out and pool into surrounding tissues.
Orladeyo is designed to prevent HAE attacks by lowering the levels of bradykinin. It does so by blocking the activity of an enzyme, called kallikrein, that helps produce it.
Data from the Phase 3 APeX-2 trial (NCT03485911), which supported Orladeyo’s approvals across various countries, showed Orladeyo was better than a placebo at lowering the rates of swelling attacks.
Real-world data also have supported the treatment’s long-term efficacy, regardless of disease severity or the use of previous preventive treatments. Orladeyo treatment also was found to significantly reduce the number of hospitalizations and emergency room visits among HAE patients in the U.S.
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 approval of Orladeyo by COFEPRIS is excellent news for the hereditary angioedema patient community in Mexico,” said 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,” Canutti said.
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