Marisa Wexler, MS, senior science writer —

The U.S. Food and Drug Administration (FDA) has lifted the hold it had placed on KalVista Pharmaceuticals’ Phase 2 KOMPLETE trial of KVD824 as a treatment to prevent swelling attacks in people with hereditary angioedema (HAE). KalVista said it is working closely with study investigators and clinical sites so…

The prices of three approved preventive treatments — Cinryze, Haegarda, and Takhzyro (lanadelumab) — for hereditary angioedema (HAE) must be reduced by more than half for these medications to be cost-effective. Those are the conclusions of a new report published by the Institute for Clinical and Economic Review,…

KalVista Pharmaceuticals announced plans to soon begin enrolling patients in KOMPLETE, a Phase 2 clinical trial testing its investigational oral therapy KVD824 in preventing swelling attacks in people with hereditary angioedema (HAE) at sites in Canada, Australia, and the U.K. “Over the past month we have made substantial progress in…

RAPIDe-1, a Phase 2 clinical trial testing Pharvaris’ investigational oral therapy PHVS416 as an on-demand treatment for swelling attacks in people with hereditary angioedema (HAE), will expand its enrollment this year to include patients in the U.S. “We are encouraged by positive feedback from clinical sites and look forward…

Treatment with Orladeyo (berotralstat) was generally safe and well-tolerated in people with hereditary angioedema (HAE), according to recently released trial data. The findings from an interim analysis of the open-label APeX-S trial also supported Orladeyo’s ability to reduce the frequency of HAE attacks, ease symptom burden, and improve…

Orchard Therapeutics and the Pharming Group are teaming up to research, develop, manufacture, and — possibly — commercialize a gene therapy for hereditary angioedema (HAE), called OTL-105. “This promising work toward treatment with the potential for durable long-term clinical benefit is encouraging and signifies an ongoing commitment to…

The U.S. Food and Drug Administration (FDA) has approved a new generic version of Firazyr (icatibant injection), a medication to treat acute swelling attacks in patients with hereditary angioedema (HAE), Glenmark Pharmaceuticals, announced in a press release. According to the India-based company, the newly approved generic will be…

Takhzyro (lanadelumab) is more effective than Cinryze at preventing swelling attacks in people with hereditary angioedema (HAE), a new study indicates. Analyses suggested that treatment with Takhzyro reduced the rates of HAE attack by 46–73% as compared with Cinryze in an indirect comparison of previous studies. Titled…

Takeda has submitted an application in Japan seeking regulatory approval of Takhzyro (lanadelumab) for the treatment of hereditary angioedema (HAE). The company’s new drug application to the Japanese Ministry of Health, Labour and Welfare (MHLW) specifically asks Takhzyro be approved for the prophylactic, or preventive, treatment of…

Long-term treatment with the approved therapy Haegarda leads to improved quality of life in people with type 1 or 2 hereditary angioedema (HAE), new clinical trial data show. The findings were published in the Orphanet Journal of Rare Diseases, in a study titled “Long-term health-related…