News

The monthly under-the-skin injection therapy garadacimab will be considered for approval for treating hereditary angioedema (HAE) in both the U.S. and the European Union. Developer CSL Behring announced that both the U.S. Food and Drug Administration and the European Medicines Agency have agreed to review applications of the therapy…

Adding a short-term regimen of C1-INH concentrate to the preventive treatment of a 63-year-old man with hereditary angioedema (HAE) enabled a successful tooth extraction without a swelling attack in his larynx, a case study reports. The tailored Orladeyo (berotralstat) prophylaxis regimen was designed to prevent an attack…

Prophylactic, or preventive, treatment with deucrictibant significantly reduced the rate of swelling attacks among adults with hereditary angioedema (HAE) in a Phase 2 clinical trial. “These study results, together with the compelling data from our on-demand program, further strengthens our confidence that deucrictibant can become the preferred option…

Argentina’s regulatory body has approved BioCryst Pharmaceuticals’ Orladeyo (berotralstat) to prevent swelling attacks in adults and adolescents, ages 12 and older, who have hereditary angioedema (HAE). The decision by the National Administration of Drugs, Foods, and Medical Devices (ANMAT) comes a few months after the approval of…

The Phase 3 KONFIDENT trial, which is testing oral sebetralstat as an on-demand treatment for hereditary angioedema (HAE), has achieved its targeted number of on-treatment swelling attacks. The trial can wrap up now that three attacks per patient were treated. Topline data is expected in early 2024. If…

A single subcutaneous or under-the-skin injection of STAR-0215 — an experimental treatment that aims to prevent swelling attacks in people with hereditary angioedema (HAE) — led to a sustained decrease in kallikrein protein activity in healthy adults for close to three months, according to new trial data. Early…

In a clinical trial, most people with hereditary angioedema (HAE) given on-demand treatment with PHVS416, an immediate-release capsule formulation of deucrictibant, saw swelling attacks begin to resolve within half an hour of taking the medication. That’s according to new data presented in a poster, titled “…

Of all the ways to wake up, my aching face in a pool of water ranked pretty low. Unfortunately, that wasn’t something I knew until it happened. After very extensive surgery to remove four wisdom teeth, I was sent home with my parents, an appropriate and necessary amount of pain…

The European Commission has expanded the approval of Takhzyro (lanadelumab) to include children with hereditary angioedema (HAE) as young as 2 years of age. This makes Takhzyro the first routine preventive, or prophylactic, treatment for HAE attacks to be approved for patients younger than 6 in the European…

The European Commission (EC) has granted orphan drug designation to NTLA-2002, an investigational gene-editing therapy that Intellia Therapeutics is developing for hereditary angioedema (HAE). The designation is given to therapies with the potential to improve medical care for people with serious conditions that affect up to five of…