Orladeyo approved in Colombia to prevent HAE swelling attacks
The OK by INVIMA follows treatment's approval in US, EU, Latin America
The oral medication Orladeyo (berotralstat) is now approved in Colombia as a preventive treatment to reduce the risk of swelling attacks in people with hereditary angioedema (HAE), ages 12 and older.
The approval, from Colombia’s National Institute of Drug and Food Surveillance (INVIMA), follows the therapy’s approval in the U.S. and European Union. Orladeyo has also been approved in other countries in Latin America, including Mexico, Peru, Brazil, Argentina, and Chile.
“[The] announcement marks another important step toward bringing Orladeyo to people living with HAE who are in need of new treatment options across the pan-Latin America region,” Charlie Gayer, chief commercial officer of Biocryst Pharmaceuticals, said in a company press release. Orladeyo was developed by Biocryst, which agreed with Pint Pharma to market and commercialize the therapy in Latin America.
“Following this positive decision from INVIMA, we are working with the team at Pint Pharma to bring our oral, once-daily prophylactic therapy to patients in Colombia,” Gayer said.
HAE is a genetic condition where recurrent swelling attacks are the result of abnormally high levels of bradykinin, a signaling molecule that causes blood vessels to widen and become more permeable. When too much bradykinin is produced, fluid leaks out into surrounding tissues, causing swelling.
How does Orladeyo work in HAE?
Orladeyo is designed to block the activity of kallikrein, an enzyme that mediates bradykinin production, thereby lowering the molecule’s levels and preventing swelling. It’s the first HAE preventive treatment that can be taken orally.
Its approval as a HAE prophylactic treatment across different regions and countries was based on data from the international Phase 3 APeX-2 trial (NCT03485911) that tested the therapy, given once daily, against a placebo in more than 100 people with HAE, ages 12 and older.
Over the initial six-month part of the trial, Orladeyo significantly reduced the frequency of swelling attacks over the placebo, particularly at the highest dose of 150 mg daily. The effect was the same in those who received treatment for nearly two years. Orladeyo was also found to be well tolerated and improve quality of life.
In a subset of 34 participants enrolled in the long-term Phase 2/3 APeX-S trial (NCT03472040) who’d switched from an injectable therapy to Orladeyo, HAE attacks remained well controlled and the patients reported higher treatment satisfaction a year after switching.
Real-world U.S. data showed Orladeyo rapidly reduced the number of swelling attacks with long-lasting effect, along with the need for hospitalizations.
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