BioCryst Pharmaceuticals Inc., headquartered in Research Triangle Park, N.C., has announced the presentation of new data on their oral, once-daily medication ORLADEYO® (berotralstat) at the European Academy of Allergy and Clinical Immunology (EAACI) meeting in Valencia, Spain. The event is scheduled to take place from May 31 to June 3, 2024.
ORLADEYO® is the first and only oral therapy specifically designed to prevent attacks of hereditary angioedema (HAE) in both adults and pediatric patients aged 12 and older. The medication works by decreasing the activity of plasma kallikrein, thus reducing the likelihood of HAE attacks. BioCryst will showcase two significant abstracts at the EAACI meeting, underscoring the effectiveness and safety of berotralstat.
The first presentation, titled "Adverse Health Outcomes and Patient and Physician Perspectives of Attenuated Androgen Use in Hereditary Angioedema," is scheduled for May 31, 2024, from 12:00 to 13:00 (CEST). This session will provide insights into the health outcomes and perspectives of both patients and physicians regarding the use of attenuated androgens in HAE treatment.
The second presentation, "Effectiveness and Safety of Berotralstat in Patients with Hereditary Angioedema with Normal C1 Inhibitor: A European Case Series," will be held on June 2, 2024, from 09:06 to 09:18 (CEST). This session will discuss the results of a European case series, emphasizing the drug's safety and efficacy in HAE patients with normal C1 inhibitors.
ORLADEYO® has been sanctioned in the U.S. as a prophylactic treatment to prevent HAE attacks in patients aged 12 and older. It is crucial to note that ORLADEYO is not intended for acute HAE attacks. Its safety and efficacy for acute treatments have not been established. Moreover, dosages higher than 150 mg once daily are not recommended due to the potential risk of QT prolongation, a heart rhythm condition.
Common side effects observed in patients taking ORLADEYO include abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease. For patients with moderate or severe hepatic impairment, a reduced dosage of 110 mg taken orally once daily with food is recommended. ORLADEYO interacts with several other drugs; for instance, P-glycoprotein inducers like rifampin and St. John’s wort may decrease berotralstat plasma concentration, reducing its effectiveness. Moreover, when co-administered with P-glycoprotein substrates like digoxin, appropriate monitoring and dose adjustments are advised.
BioCryst Pharmaceuticals is a global biotechnology firm dedicated to improving the lives of individuals with rare diseases. The company's expertise in structure-guided drug design has enabled them to develop first-in-class oral small-molecule and protein therapeutics for difficult-to-treat conditions. ORLADEYO® represents a significant milestone as the first oral, once-daily plasma kallikrein inhibitor, reflecting BioCryst's commitment to innovation and patient care.
The forthcoming EAACI meeting will provide an excellent platform for BioCryst to share these pivotal findings with the medical community, further solidifying the clinical potential of ORLADEYO® in treating hereditary angioedema.
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