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…
The U.S. Food and Drug Administration (FDA) has agreed to review Kalvista Pharmaceuticals’ application seeking the approval of sebetralstat as an on-demand treatment for swelling attacks in people 12 and older with hereditary angioedema. Regulators expect to make their decision on the new drug application (NDA) the…
An algorithm that takes into account factors such as the frequency and location of swelling attacks may help distinguish chronic histaminergic angioedema (CHA), which is a form of angioedema, from chronic spontaneous urticaria (CSU), a disorder with similar symptoms. That’s according to a study, “Predictive…
Hereditary angioedema (HAE) patients in South Australia are generally satisfied with their prophylactic (preventive) treatment regimens, a study found. Danazol appeared to be a popular choice for patients with milder disease, while newer therapies like C1 esterase inhibitor (C1-INH) products and Takhzyro (lanadelumab) were preferred for patients…
Regulatory authorities in Japan, the U.S., and the European Union have aligned on plans for a Phase 3 clinical trial to test the oral medication deucrictibant as a prophylactic (preventive) treatment to reduce the risk of swelling attacks in people with hereditary angioedema (HAE). With alignment from the U.S.
Authorities in the European Union (EU) have agreed to review Kalvista Pharmaceuticals’ application requesting the approval of oral sebetralstat as an on-demand treatment for swelling attacks in people with hereditary angioedema (HAE). The company’s marketing authorization application (MAA) now will be reviewed by a committee of…
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