Steve Bryson, PhD,  science writer—

KalVista Pharmaceuticals has launched a two-year open-label extension (OLE) study, dubbed KONFIDENT-S, to test the long-term safety of oral sebetralstat (formerly known as KVD900) as an on-demand treatment for swelling attacks caused by hereditary angioedema (HAE). The study follows the ongoing Phase 3 KONFIDENT clinical trial, involving adults and…

Regulatory authorities in Saudi Arabia have approved daily Orladeyo (berotralstat) to prevent hereditary angioedema (HAE) attacks in adult and adolescent patients, ages 12 and older. “There is a significant need for new treatment options for HAE in Saudi Arabia,” Charlie Gayer, chief commercial officer of BioCryst Pharmaceuticals,…

STAR-0215, an investigational therapy to prevent swelling attacks in people with hereditary angioedema (HAE), rapidly and durably suppressed the enzyme kallikrein, supporting a once every three months or longer dosing in humans, according to new preclinical data. The data was recently presented in a flash talk titled, “…

Treatment with sebetralstat, an investigational and oral on-demand therapy, resulted in rapid relief for both abdominal and peripheral attacks in adults with hereditary angioedema (HAE), according to a new analysis Phase 2 trial data. Sebetralstat (formerly KVD900), by KalVista Pharmaceuticals, is a small molecule inhibitor of the…

The one-year Phase 3 SPRING study evaluating the safety, efficacy, and pharmacological properties of Takhzyro (lanadelumab) in children with hereditary angioedema (HAE), ages 2 to 11, succeeded in meeting its goals, Takeda, which markets the treatment, announced. Based on these findings, the company plans to file applications…

CSL Plasma has donated $125,000 to the American Red Cross to support recovery and relief efforts following disasters in the U.S., including tornadoes, hurricanes, wildfires, residential fires, and floods. These disasters can affect areas where plasma donors live and where employees involved in the manufacturing of plasma-derived therapies…

Enrollment is open for the open-label, Phase 1/2 HAERMONY trial to evaluate the safety and effectiveness of BMN 331, an investigational gene therapy for hereditary angioedema (HAE). The trial’s sponsor, BioMarin Pharmaceutical, plans to recruit about 34 adults with type 1 or type 2 HAE at one site…

KVD900, an investigational on-demand therapy for hereditary angioedema (HAE), rapidly and nearly completely suppressed kallikrein and was generally safe and well tolerated in healthy volunteers, according to Phase 1 studies. These findings, which have since been confirmed in a Phase 2 trial, supported the planned launch of…

KalVista Pharmaceuticals is planning to launch a Phase 3 trial of KVD900, an investigational oral and on-demand treatment for adults with hereditary angioedema (HAE), with dosing expected to begin in early 2022. “Our development team is finalizing the Phase 3 trial protocol and preparing for study initiation,…

Orladeyo (berotralstat) reduced the frequency of swelling attacks in people with hereditary angioedema (HAE) and improved their quality of life over the course of one year, according to the latest findings from the long-term APeX-S trial. The approved oral medication also was able to sustainably lower HAE attack…