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…
Biocryst Pharmaceuticals has sold the European rights to Orladeyo (berotralstat), its approved oral therapy for preventing swelling attacks in people with hereditary angioedema (HAE), to the Italian pharmaceutical company Neopharmed Gentili. Under the terms of the deal, according to a Biocryst press release, the company “will…
Acquired angioedema was the first sign of an underlying extranodal marginal zone lymphoma (EMZL) — a type of non-Hodgkin lymphoma — in a 45-year-old woman, according to a case study. After a comprehensive evaluation involving cancer and immunology specialists, she received treatment with rituximab. The therapy resolved her…
Ekterly (sebetralstat) is now approved by both the European Commission and Swissmedic as an on-demand treatment to manage swelling attacks in people with hereditary angioedema (HAE), ages 12 and older. These new approvals, which come on the heels of similar approvals in the U.S. and the…
Patient enrollment has been completed in a global Phase 3 clinical trial that’s evaluating lonvoguran ziclumeran, also known as lonvo-z (NTLA-2002), a gene-editing therapy Intellia Therapeutics is developing to prevent swelling attacks in people with hereditary angioedema (HAE). Dubbed HAELO (NCT06634420), the trial — which…
Deucrictibant, an experimental treatment for angioedema attacks, was well tolerated and effective in four patients with acquired angioedema due to C1-inhibitor deficiency (AAE-C1INH), according to a study. The proof-of-concept trial found that the “deucrictibant extended-release tablet effectively prevented angioedema attacks in patients with AAE-C1INH, with no safety concerns,”…
Late-treated and untreated swelling attacks in people with hereditary angioedema (HAE) are associated with a lower health-related quality of life and work productivity. That’s according to a U.S. study, which also found that as attack severity and time to treatment increased, patients’ quality of life and work productivity decreased.
New hereditary angioedema (HAE) preventive treatment Dawnzera (donidalorsen) will now be available in the U.S. to adults and adolescents, ages 12 and older, through the specialty pharmacy Orsini. Following the therapy’s approval late last month as a prophylaxis for HAE swelling attacks, developer Ionis Pharmaceuticals partnered with…
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…
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