The New Drug Application (NDA) for berotralstat (BCX7353; BioCryst) for the prevention of hereditary angioedema (HAE) attacks has been submitted to the Food and Drug Administration.
This article is part of MPR‘s coverage of the ACAAI 2019 meeting, taking place in Houston, TX. Our staff will report on medical research related to allergies, asthma, and more conducted by experts in the field. Check back regularly for more news from ACAAI 2019. Data from the open-label extension (OLE) portion of the phase…
The oral plasma kallikrein inhibitor, BCX7353, reduced hereditary angioedema attacks during a 24-week treatment period.
Results from a phase 3 trial evaluating BCX7353 (BioCryst), an investigational therapy for hereditary angioedema (HAE), showed that the oral plasma kallikrein inhibitor significantly reduced the rate of HAE attacks, the primary endpoint of the study.
This article is part of MPR‘s coverage of the American Academy of Allergy, Asthma & Immunology annual meeting, taking place in San Francisco, California. Our staff will report on medical research related to asthma, allergy, and other respiratory conditions, conducted by experts in the field. Check back regularly for more news from AAAAI 2019. Researchers sought to examine…
During the treatment period, the mean number of attacks per month was 1.97 for placebo and 0.48, 0.53, and 0.26 for the lanadelumab groups, respectively. The mean differences in the attack rate per month compared with placebo were −1.49, −1.44, and −1.71, respectively.
Patients with hereditary angioedema who received lanadelumab exhibited few cases of hypersensitivity and had low immunogenicity.
The Company filed the sBLA last November following FDA feedback on two completed Phase 2 trials of Ruconest for prophylaxis of HAE attacks.
ADVM-053 is being developed as a single‑administration treatment that could potentially provide sustained levels of the C1 esterase inhibitor protein, which may prevent breakthrough angioedema attacks.
The approval was based on data from 4 clinical trials, including the 26-week Phase 3 HELP (Hereditary Angioedema Long-Term Prophylaxis) study that enrolled 125 patients with HAE aged ≥12 years.
