News

Cancer treatment works to control acquired angioedema in elderly man

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…

Phase 3 trial to test extended deucrictibant as treatment for HAE

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…

Data show sustained benefits of deucrictibant for HAE attacks

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…

FDA to consider sebetralstat as on-demand treatment for HAE

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…

Patients satisfied with preventive treatment: Australian study

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…

Preparations underway for Phase 3 trial of deucrictibant

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.

Sebetralstat under approval review in EU as on-demand HAE therapy

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…

Phase 3 trial of NTLA-2002, gene-editing therapy, possible in 2024

A single dose of the gene-editing therapy NTLA-2002 led to significant reductions in the number of swelling attacks among people with hereditary angioedema (HAE) in a Phase 2 clinical trial. NTLA-2002’s developer, Intellia Therapeutics, announced the study met its main goal, demonstrating that the investigative gene therapy…