Author Archives: Marta Figueiredo PhD

The United Arab Emirates (UAE) has approved BioCryst Pharmaceuticals’ Orladeyo (berotralstat) for preventing hereditary angioedema (HAE) attacks in patients, 12 and older. “As the first targeted oral, once-daily treatment, Orladeyo provides an important new treatment option for patients and physicians,” Henrik Balle Boysen, executive vice president and chief operating…

Regulatory health agencies in Canada and Switzerland are reviewing BioCryst Pharmaceuticals’ applications for the approval of Orladeyo (berotralstat) in their countries for preventing hereditary angioedema (HAE) attacks in patients ages 12 and older. The applications — to Heath Canada and Swissmedic — followed Orladeyo’s recent approvals in the…

Higher blood levels of molecules involved in blood vessel formation and permeability — Tie-2, Ang-2, and VE-Cadherin — along with sE-selectin, which is involved in vascular inflammation, may help to distinguish different types of angioedema, a study suggests. Notably, Tie-2 may be a biomarker of hereditary angioedema (HAE),…

Multiple doses of PHA121 (PHA-022121), an investigational oral therapy for hereditary angioedema (HAE), were well-tolerated and rapidly reached therapeutic levels in healthy volunteers, according to data from a Phase 1 clinical trial. The therapy’s pharmacological profile “suggests that the therapeutic effect of PHA121 can be achieved as early…

PHA121 (PHA-022121), Pharvaris’ experimental oral therapy for hereditary angioedema (HAE), results in faster, more potent, and more durable suppression of bradykinin-induced changes in blood pressure than injectable Firazyr (icatibant), according to studies in monkeys and healthy volunteers. These findings, along with evidence of PHA121’s favorable pharmacological…

Orladeyo (berotralstat), an oral therapy to prevent hereditary angioedema (HAE) attacks, is now available to patients, 12 and older, in Germany. “We have an experienced team in place in Germany that is excited and honored to bring the first oral, once daily therapy to HAE patients in Europe,”…

The European Commission has approved BioCryst Pharmaceuticals’ Orladeyo (berotralstat) as the first oral, daily therapy to prevent swelling attacks in adults and adolescents, ages 12 and older, with hereditary angioedema (HAE). An oral preventive therapy should be easier to take than standard under-the-skin and into-the-vein alternatives, and as…

Haegarda, CSL Behring’s preventive treatment for hereditary angioedema (HAE) attacks, will be available to eligible HAE patients across Canada starting on April 6. The availability announcement was issued by Canadian Blood Services (CBS), the country’s blood authority, which is responsible for managing the blood supply in all…

Intellia Therapeutics is advancing clinical manufacturing activities to support its plans to file regulatory applications for first-in-human clinical trials of NTLA-2002, its experimental gene-editing therapy for hereditary angioedema (HAE). The submissions are anticipated in the second half of the year, and the first trial is expected to evaluate…

BioCryst Pharmaceuticals’ Orladeyo (berotralstat) has been recommended for approval in the European Union as the first oral therapy for preventing swelling attacks in people with hereditary angioedema (HAE), ages 12 and older. The recommendation was made by the Committee for Medicinal Products for Human Use (CHMP), an arm…