A Phase 3 trial testing BCX7353, an inhibitor of plasma kallikrein for the prevention of swelling attacks in hereditary angioedema (HAE) patients, has dosed its first participant, BioCryst Pharmaceuticals announced. The trial, APeX-2, will include roughly 100 patients with type 1 and type 2 hereditary angioedema in several centers in the…
Lanadelumab, an antibody that binds and inhibits plasma kallikrein, effectively reduces the number of swelling attacks and improves quality-of-life scores in patients with hereditary angioedema (HAE) when used as a preventive treatment, new data from the Phase 3 HELP study shows. The findings, which support the clinical benefits of lanadelumab as…
A long-term clinical trial testing BCX7353’s ability to prevent hereditary angioedema (HAE) attacks is dosing its first group of participants, BioCryst Pharmaceuticals announced. “Initiation of the APeX-S trial is an important milestone to support filing and approval of BCX7353, and furthers our core strategy of bringing a once-daily, oral prophylactic…
Long-term treatment with human plasma-derived C1 inhibitor may help women with hereditary angioedema get pregnant and carry out the pregnancy to full term without risking complications, a case report suggests. The study, from a hospital in Valencia, Spain, titled, “Successful long-term prophylaxis with human plasma-derived C1 inhibitor in…
The biopharmaceutical company Shire is expected to soon submit a biologics license application to the U.S. Food and Drug Administration (FDA) seeking marketing approval of its investigational monoclonal antibody lanadelumab as therapy for patients with hereditary angioedema. The application is supported by positive results from the company’s Phase 3 HELP…
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