Author Archives: Forest Ray PhD

Fewer HAE Attacks Evident With Takhzyro Use in Canadian Study

Use of Takhzyro (lanadelumab) for at least six months led to fewer hereditary angioedema (HAE) attacks and treated attacks, a case review study from Canada reported. Three of its 12 patients went into complete remission, and all enjoyed a more comfortable social life, the investigators noted. The study, by…

FDA Approves Combo Kit for Easier At-home Use of Berinert

The U.S. Food and Drug Administration (FDA) has approved a new convenience administration kit for people using Berinert, an at-home infusion treatment of acute hereditary angioedema (HAE) attacks in children and adults. This kit is designed to provide all the components needed for at-home treatment, making Berinert’s use easier…

Therapies to Improve Mental Health Needed in HAE Management

Effective management of hereditary angioedema (HAE) should include addressing psychological and mental health, given that depression, stress, and anxiety are “prevalent” among patients and can place a considerable burden on those with the chronic genetic disease, a study reported. Indeed, according to researchers, “all participants [in this study] experienced…

UK Agency Approves Orladeyo to Prevent HAE Attacks

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing approval to BioCryst Pharmaceuticals’ Orladeyo (berotralstat), as the first oral and daily therapy to prevent acute attacks of hereditary angioedema (HAE) in individuals ages 12 and older. “HAE UK welcomes the decision from the MHRA…

Orladeyo Now Reimbursable in Japan via National Health Insurance

Japan’s National Health Insurance System (NHI) has approved the addition of Orladeyo (berotralstat), an oral preventive treatment for hereditary angioedema (HAE) attacks, to its drug price list. This means that the NHI will reimburse hospitals and pharmacies prescribing Orladeyo to a certain amount under national health insurance programs.

Orladeyo Now Available in France Via Early Access Program

Orladeyo (berotralstat) — an oral therapy developed by BioCryst Pharmaceuticals to prevent swelling attacks in people with hereditary angioedema (HAE) — is now available to patients, 12 and older, in France, following a decision by a government agency. The French National Agency for Medicines and Health Products Safety granted…

First Patient Dosed in Phase 2 Trial Testing PHVS416 for HAE Attacks

The first patient has been dosed in RAPIDe-1, a Phase 2 trial of PHVS416, an oral on-demand treatment being developed by Pharvaris for swelling attacks in people with hereditary angioedema (HAE). RAPIDe-1 (NCT04618211) will evaluate the investigational therapy’s safety, efficacy, and pharmacokinetics, or how the compound moves…