News

Hereditary angioedema (HAE) patients who took Takhzyro (lanadelumab-flyo) for at least three years saw reductions in the frequency and severity of attacks and found that their quality of life improved, data from a U.S. study showed. The study, “Long-term Real-world Outcomes in Patients with Hereditary Angioedema…

The U.S. Food and Drug Administration (FDA) has approved donidalorsen — to be marketed Dawnzera — as a prophylactic treatment for swelling attacks in adults and adolescents, ages 12 and older, with hereditary angioedema (HAE). With this decision, Dawnzera has become the first and only RNA-targeted therapy approved for…

Pharvaris said it’s on track to launch a pivotal Phase 3 trial of deucrictibant to treat and prevent swelling attacks in people with acquired angioedema by year-end. The three-part study, called CREAATE, will evaluate deucrictibant’s potential as both an on-demand therapy to control active swelling as it occurs,…

The oral on-demand treatment candidate sebetralstat for hereditary angioedema (HAE) is getting to keep its orphan drug status in the European Union, developer Kalvista Pharmaceuticals announced. According to a press release from the company, the European Medicines Agency (EMA) has decided to maintain the therapy’s orphan drug designation,…

A monthly injection therapy developed by CSL Behring has won approval from Health Canada to prevent swelling attacks in people with hereditary angioedema (HAE), ages 12 and older. The approval of Andembry (garadacimab-gxii) follows approvals this year in the U.S., the European Union, the…

Kaken Pharmaceutical has secured the rights to develop and commercialize navenibart, an investigational treatment for hereditary angioedema (HAE), in Japan. Kaken will pay $16 million as part of an agreement with navenibart developer Astria Therapeutics that includes another $16 million if development and sales milestones are…

Delays in administering on-demand treatment are common in hereditary angioedema (HAE), with 51% of patients receiving treatment more than two hours after the onset of an attack, according to a survey in Italy that found that delaying treatment correlates with greater attack severity. The findings underscore the need to…

Haloperidol, an antipsychotic medication commonly used to treat schizophrenia and severe agitation, was behind a rare case of angioedema of the tongue — a sudden, potentially life-threatening swelling — for a man in Tunisia, as detailed a case report. Although angioedema can occur as an allergic reaction or as…

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended that sebetralstat be approved as an on-demand treatment for acute attacks in people with hereditary angioedema (HAE), ages 12 and older. “This positive CHMP opinion is an important step forward for people living…

People with hereditary angioedema (HAE) types 1 and 2 had fewer swelling attacks and reported improvements in quality of life after they switched to donidalorsen from other preventive therapies, according to interim data from an ongoing clinical trial. “The study was designed to provide patients and physicians with…