News

The U.S. Food and Drug Administration (FDA) has approved Andembry (garadacimab-gxii) to prevent swelling attacks caused by hereditary angioedema (HAE) in adults and adolescents, ages 12 and older, adding the U.S. to the countries where the medication is available. Developed by CSL Behring, it’s the only treatment…

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…

Orladeyo is now approved for reimbursement in the Netherlands following a recommendation from healthcare government agency Zorginstituut Nederland. The treatment is used for routine prevention, or prophylaxis, of swelling attacks in people 12 years and older with hereditary angioedema (HAE). With this decision, Orladeyo…

Kalvista Pharmaceuticals’ sebetralstat, an oral on-demand treatment for hereditary angioedema (HAE), rapidly stopped the progression of swelling attacks, according to interim data from a two-year open-label extension study. It was also effective against attacks involving the larynx (voice box) and abdomen, as well as those rated as severe or…

Recognizing a problem early and treatment can help avoid life-threatening complications when swelling of the larynx, or voice box, caused by hereditary angioedema (HAE) blocks the airways. That’s according to a report that describes the case of a man in China with hereditary angioedema-induced laryngeal edema (HALE), which can…

The use of Orladeyo (berotralstat) — widely approved as a preventive treatment for hereditary angioedema (HAE) — can help reduce the rates of swelling attacks in people with HAE of different ages, according to new data from clinical trials and real-world analyses. Biocryst Pharmaceuticals, the developer of the…

A new scoring system may help emergency physicians diagnose hereditary angioedema (HAE), potentially allowing patients to receive treatment faster, a study found. Nine HAE experts worked together to design the system, which assigns patients numerical scores based on their symptoms, family history, and responsiveness to certain treatments. “This tool…

Treatment with the daily oral therapy Orladeyo (berotralstat) can effectively reduce swelling attack rates in people with hereditary angioedema (HAE) who experienced many such attacks before starting on the therapy, real-world data showed. Additional real-world data indicated that Orladeyo is also effective for preventing swelling attacks in adolescents…

Donidalorsen, a preventive therapy being developed to reduce the frequency of swelling attacks for people with hereditary angioedema (HAE), significantly improved quality of life and symptom control for people with the condition, a new analysis of clinical trial data suggests. Ionis Pharmaceuticals, donidalorsen’s developer, funded the study,…

The U.S. Food and Drug Administration (FDA) has accepted Biocryst Pharmaceuticals’ application to approve an oral granule formulation of Orladeyo (berotralstat) for children with hereditary angioedema (HAE) as young as 2. The FDA granted the application priority review, which shortens the process from the standard 10 months…