Intellia Therapeutics has launched a Phase 3 clinical trial to evaluate the efficacy and safety of NTLA-2002, a single-dose gene-editing therapy for people with hereditary angioedema (HAE). The new trial, dubbed HAELO (NCT06634420), was given the green light by the U.S. Food and Drug Administration (FDA) based…
Kalvista Pharmaceuticals has submitted applications to regulatory authorities in the U.K., Switzerland, Australia, and Singapore requesting the approval of sebetralstat, an oral, on-demand treatment for hereditary angioedema (HAE) in patients ages 12 and older. The four applications were submitted through the Access Consortium framework, a coalition of…
The U.S. Food and Drug Administration (FDA) has granted orphan drug status to navenibart — the new generic name of Astria Therapeutics’ experimental therapy STAR-0215 — as a treatment for hereditary angioedema (HAE).
People with hereditary angioedema (HAE) in Japan with access to on-demand therapies alone can have a high rate of attack frequency — weekly or monthly — that associates with a poorer quality of life, a study in that country reports. Patients’ functioning, fears, and feelings of shame significantly linked…
A man who experienced recurrent episodes of tongue swelling was diagnosed with angioedema related to the use of an angiotensin-converting enzyme (ACE) inhibitor to treat high blood pressure, according to a case report. The patient’s symptoms eased after stopping treatment with the medication, lisinopril, with no recurrence of angioedema…
Treatment with Takhzyro (lanadelumab), an injectable antibody therapy, led to a mean reduction of 94.7% in monthly hereditary angioedema (HAE) attacks in adolescents with HAE, according to findings of a Phase 3 extension study. These results, which focused on a subgroup of 21 patients with type 1…
Orladeyo (berotralstat), an approved oral treatment to prevent attacks in hereditary angioedema (HAE) patients 12 years and older, is one step closer to being eligible for reimbursement under public drug plans in Canada, according to its developer, Biocryst Pharmaceuticals. Biocryst has successfully completed negotiations with the pan-Canadian…
The case of an elderly man who developed acquired angioedema associated with an underlying blood disorder called monoclonal gammopathy was described in a new report, with the researchers noting the condition is “very rare but serious.” The man’s angioedema was controlled only after the underlying monoclonal gammopathy was successfully…
Pharvaris said it plans to initiate a Phase 3 clinical trial by the end of the year to test an oral, extended-release tablet formulation of deucrictibant as a preventive, or prophylactic, treatment for hereditary angioedema (HAE). Called CHAPTER-3, the trial will assess the treatment’s safety and efficacy…
Treatment with deucrictibant continued to successfully prevent and treat swelling attacks in people with hereditary angioedema (HAE), according to new data from the open-label extension portions of two clinical trials. The findings, presented at the Bradykinin Symposium held in Berlin Sept. 5-6, support the use of deucrictibant…
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