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…
Astria Therapeutics is teaming up with Ypsomed, a Swiss-based company, to develop an autoinjector for its experimental treatment STAR-0215 for hereditary angioedema (HAE). “With STAR-0215’s profile, our goal is to develop a therapy that allows patients to choose an approach that works best for their lives with…
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…
Many people with hereditary angioedema (HAE) delay on-demand treatment for their attacks because they think the swelling isn’t severe enough or due to high costs and challenges related to injection, which can worsen symptoms, a survey study finds. “Survey results highlight that decision making regarding on-demand treatment in HAE…
Race and geographic disparities are common in clinical trials of hereditary angioedema (HAE), with non-white patients and countries outside the U.S. and Europe underrepresented, a study by an international team of researchers has found. While participation from European and Asian nations in HAE trials has increased significantly in the…
People with non-hereditary angioedema living with a substance use disorder (SUD) have a significantly elevated risk of breathing-related hospitalizations and complications, according to a U.S. nationwide study involving more than 140,000 people. The increased risk applied to all subtypes of SUD, including excessive use of alcohol, tobacco, cannabis, cocaine,…
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