Marisa Wexler, MS,  senior science writer—

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…

Throughout 2023, we at Angioedema News have been bringing you coverage of the latest news related to angioedema, from basic research to clinical trials and advances in treatment. Here we’ve compiled a list of the top 10 most-read articles we’ve published this past year. We look forward to…

The monthly under-the-skin injection therapy garadacimab will be considered for approval for treating hereditary angioedema (HAE) in both the U.S. and the European Union. Developer CSL Behring announced that both the U.S. Food and Drug Administration and the European Medicines Agency have agreed to review applications of the therapy…

Prophylactic, or preventive, treatment with deucrictibant significantly reduced the rate of swelling attacks among adults with hereditary angioedema (HAE) in a Phase 2 clinical trial. “These study results, together with the compelling data from our on-demand program, further strengthens our confidence that deucrictibant can become the preferred option…