Orladeyo approved in Peru as preventive HAE treatment

Approval follows OKs from Mexico, Brazil, Argentina, Chile

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The oral medication Orladeyo (berotralstat) is now approved in Peru as a prophylactic, or preventive, treatment to reduce the risk of swelling attacks in people with hereditary angioedema (HAE), ages 12 and older.

The approval from Peru’s General Directorate of Medicines, Supplies and Drugs comes just months after Orladeyo was approved in Mexico for the same indication. Orladeyo also has been approved in BrazilArgentina, and Chile, as well as in the U.S. and Europe.

“We are excited that patients in Peru will soon be able to benefit from our oral, once-daily prophylactic therapy,” Charlie Gayer, chief commercial officer of Biocryst Pharmaceuticals, said in a company press release.

Biocryst is the original developer of Orladeyo. In Latin America, the therapy is being developed and distributed by Pint Pharma under a 2022 agreement. “We continue to work alongside our partner, Pint Pharma, to bring Orladeyo to people living with HAE who are in need of new treatment options across the pan-Latin America region,” Gayer said.

The approval “is excellent news for the community of patients with hereditary angioedema in Peru,” Valnei Canutti, chief scientific affairs officer at Pint, said in a separate press release.

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Most HAE patients surveyed say they can predict swelling attacks

Data show therapy’s effectiveness

HAE is characterized by swelling attacks driven by the overproduction of bradykinin, a signaling molecule. Too much bradykinin causes blood vessels to leak and allows fluid to accumulate in surrounding tissues, ultimately causing swelling. Bradykinin’s production is mediated by an enzyme called kallikrein.

Orladeyo is designed to block the activity of the kallikrein enzyme, thereby reducing bradykinin levels to prevent swelling. Although other prophylactic HAE treatments have been available, Orladeyo is the first that can be taken orally.

In a Phase 3 clinical trial called APeX-2 (NCT03485911), the oral therapy was shown to be better than a placebo at preventing swelling attacks, with consistent effects for up to nearly two years of treatment.

Real-world U.S. data have consistently indicated that Orladeyo can help lessen swelling attacks, improve patients’ quality of life, and limit the need for hospitalizations in people with HAE.

“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.