Marisa Wexler, MS, senior science writer —

The once-daily oral therapy Orladeyo (berotralstat) has been approved in Brazil to prevent swelling attacks in people, 12 and older, with hereditary angioedema (HAE). The approval by the Brazilian Health Regulatory Agency (ANVISA) makes Orladeyo the first oral prophylactic (preventive) therapy authorized for HAE patients in the country.

Treatment with the experimental under-the-skin injection therapy STAR-0215 reduced the rates of monthly swelling attacks by more than 90% in people with hereditary angioedema (HAE) in a small early clinical trial. That’s according to new data announced by developer Astria Therapeutics, which further showed that HAE attacks…

Pharvaris has started a Phase 3 clinical trial called RAPIDe-3 to test an immediate-release capsule formulation of deucrictibant as an on-demand treatment to manage swelling attacks in hereditary angioedema (HAE). “We hear from the HAE community that rapid onset and complete resolution of angioedema attacks with a single,…

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has awarded promising innovative medicine designation to sebetralstat, an experimental oral therapy KalVista Pharmaceuticals is developing as an on-demand treatment to resolve swelling attacks in hereditary angioedema (HAE). The designation is the first step in the Early Access…

Orladeyo (berotralstat), an oral therapy for preventing swelling attacks in adults and adolescents with hereditary angioedema (HAE), is now available in Italy. The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA), has finalized reimbursement and is recommending Orladeyo as a routine prophylactic (preventive) treatment for people with HAE,…

Note: This story was updated March 12, 2024, to clarify the data pertaining to the proportion of sebetralstat-treated swelling attacks seen in HAE patients taking part in the KONFIDENT trial. A single dose of oral sebetralstat — not the two allowed in trial — was sufficient to ease or…

Birth control pills and other changes in hormone levels are a common trigger for swelling attacks among women with rare forms of hereditary angioedema (HAE), according to a new study of patients in Portugal. “The main identified triggers were oral estrogen-containing contraceptives (in 24 of 24 women; 100%),” the…

On-demand treatment with the experimental oral medication sebetralstat was effective for resolving swelling attacks in people with hereditary angioedema (HAE) — meeting all endpoints, or goals, in the Phase 3 KONFIDENT trial — top-line data show. Based on the positive findings, sebetralstat’s developer KalVista Pharmaceuticals is planning…

The U.S. Food and Drug Administration (FDA) has lifted its clinical hold on deucrictibant as a prophylactic, or preventive, treatment for hereditary angioedema (HAE) attacks. Deucrictibant developer Pharvaris said it will resume clinical testing of the therapy in HAE, including restarting the open-label extension part of the…

With Phase 3 clinical trial results on Ionis Pharmaceuticals’ donidalorsen for hereditary angioedema (HAE) due by mid-year, the company has struck a deal with Otsuka Pharmaceutical for the  commercialization of the preventive treatment in Europe. “We are excited to collaborate with Otsuka given their proven results in bringing…