A European Medicines Agency (EMA) committee recommended that Dawnzera (donidalorsen) be approved to prevent swelling attacks in hereditary angioedema (HAE) patients 12 and older. The positive opinion comes from the EMA’s Committee for Medicinal Products for Human Use (CHMP), which is tasked with reviewing safety and efficacy data…
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Ekterly (sebetralstat), given as a tablet that dissolves on the tongue, resulted in early, effective, and safe management of swelling attacks in children with hereditary angioedema (HAE) aged 2-11, according to interim data from a clinical trial. The ongoing Phase 3 study, KONFIDENT-KID (NCT06467084), which has enrolled…
While the treatment landscape for people with hereditary angioedema (HAE) has improved significantly in the last decades, symptoms such as uncontrolled swelling attacks — occurring despite the use of on-demand or long-term preventive therapies — have resulted in low health-related quality of life (HRQoL) among patients, particularly women and those with…
A young man in Greece developed acquired angioedema, one of the rarest forms of angioedema, as a complication of Mycoplasma pneumoniae infection — the bacterium best known for causing lung infection, or pneumonia — according to a recent case report. While being treated for pneumonia, the man suddenly…
The first adult participant with hereditary angioedema (HAE) has been dosed in STOP-HAE, a Phase 3 clinical trial evaluating the efficacy of ADARx Pharmaceuticals’ investigational therapy ADX-324. Designed as a long-acting preventive treatment, ADX-324 aims to reduce the frequency of swelling attacks while requiring fewer injections. The…
A man in the U.S. developed nonallergic angioedema on his tongue after he ran out of his blood-pressure medication and took his spouse’s lisinopril, another medication used to lower blood pressure, for two weeks. The man had experienced a swelling episode from lisinopril (brand name Qbrelis, among others), an…
Many patients in Brazil lack access to first-line treatments such as Takhzyro (lanadelumab) to prevent swelling attacks in hereditary angioedema (HAE), a study found. “Despite recent advances, access to first-line therapies for long-term prophylaxis of HAE attacks remains limited,” the researchers wrote. These limitations “may likely be encountered in…
Biocryst Pharmaceuticals is preparing to acquire Astria Therapeutics, and with it navenibart, a still-experimental, long-acting prophylactic (preventive) treatment that could improve care for people with hereditary angioedema (HAE) by reducing how often patients need injections. Navenibart is now in Phase 3 clinical testing, after earlier data…
For most people with hereditary angioedema (HAE) given on-demand treatment in clinical trials with the now-approved therapy Ekterly (sebetralstat), swelling attacks stopped getting worse within 20 minutes of the oral medication being administered. That’s according to new data that Kalvista Pharmaceuticals, Ekterly’s developer, shared earlier this month…
Patient enrollment has started at sites in the European Union for a global Phase 3 clinical trial evaluating the safety and efficacy of navenibart, an antibody-based therapy designed to prevent swelling attacks in people with hereditary angioedema (HAE). Dubbed ALPHA-ORBIT trial (NCT06842823), the pivotal trial is testing the…