BioCryst announces publication of data from open-label extension of the APEX-2 pivotal trial of Orladeyo (berotralstat)
Biocryst Pharmaceuticals Inc today announced that data from the open-label extension (OLE) of the APeX-2 trial of oral, once-daily, Orladeyo for the prophylactic treatment of hereditary angioedema (HAE) in patients 12 years and older have been published online by the Journal of Allergy and Clinical Immunology: In Practice (JACI: In Practice).
William R. Lumry, MD, Clinical Professor of Internal Medicine at the University of Texas Southwestern Medical School, said: “As detailed in this manuscript, long-term prophylaxis with ORLADEYO has enabled patients with HAE to better manage their condition, including reducing the number of HAE attacks they experience and demonstrating clinically meaningful improvement in their quality of life. I have seen first-hand in my practice evidence that the longer patients remain on ORLADEYO, the better their outcomes are.”
Dr Ryan Arnold, Chief Medical Officer of BioCryst, said: “We are pleased to share long-term efficacy and safety data from APeX-2 as published in JACI: In Practice. These data further illustrate the potential lasting outcomes that can be appreciated by patients who are treated with oral, once-daily ORLADEYO. We continue to see long-term safety and effectiveness data that reinforce ORLADEYO as an important treatment option for patients with HAE, and we look forward to sharing additional real-world evidence at upcoming medical congresses.”
(Source: BioCryst)
