Data from APeX-S showed patients had more than 80 percent attack free months after switching to ORLADEYO from injectable prophylactic therapies
RESEARCH TRIANGLE PARK, N.C., Nov. 05, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced new long-term efficacy and safety data from studies evaluating oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE), including results showing sustained reduction of HAE attack rates and improved patient satisfaction after patients switched to ORLADEYO monotherapy from injectable prophylactic therapies (lanadelumab and C1 inhibitors).
The data are being presented at the 2021 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI), which is being conducted in New Orleans, Louisiana, and online, from November 4-8, 2021.
“We continue to see improvement in key indicators that demonstrate the value of oral, once-daily ORLADEYO as an excellent option for patients who want alternatives to injectable prophylactic therapies, which carry a high treatment burden,” said Dr. William Sheridan, chief medical officer of BioCryst. “The data we are presenting at ACAAI further support ORLADEYO as a transformative therapy for HAE patients, including those who are already well-controlled on other therapies.”
“The data from APeX-S showed that HAE patients who switched to ORLADEYO from an injectable prophylactic therapy had more than 80 percent attack free months,” said Marc Riedl, M.D., clinical director of the US HAEA Angioedema Center at the University of California San Diego. “These data show that, regardless of which therapy patients switched from, or when they switched, ORLADEYO provided consistently low attack rates when used as a monotherapy. These important findings add to real-world evidence that this oral, once-daily therapy is a beneficial treatment option for many HAE patients.”
“Increased satisfaction and improvement in quality of life continue to be major driving factors for patients who decide to switch to an oral prophylactic option, as shown in our analysis of patients who switched from injectable prophylaxis to ORLADEYO in APeX-2,” said Jonathan Bernstein, M.D., professor of medicine, department of internal medicine, division of allergy & immunology at the University of Cincinnati and partner of the Bernstein Allergy Group and Bernstein Clinical Research Center. “These results underscore what I see every day in clinical practice, that HAE patients want a more convenient treatment option to control their HAE attacks and reduce their overall burden of therapy.”
BioCryst ACAAI 2021 Presentation Highlights
- Consistently Low Hereditary Angioedema (HAE) Attack Rates Observed in US Patients Treated with Berotralstat (Distinguished Industry Oral Presentation)
- Highlights safety, effectiveness and patient-reported outcomes of ORLADEYO 150 mg in U.S. patients from APeX-S who completed 12 months of treatment (n=71).
- Following initiation of ORLADEYO, patients experienced low HAE attack rates that were sustained throughout the treatment period (median attack rate of 0.0 attacks per month through month 12), consistent with previously reported data.
- ORLADEYO was associated with prompt, sustained, statistically significant and clinically meaningful improvements in quality of life (-10.8 change from baseline at month 1 and -13.6 change from baseline at months 6 and 12; p