The FDA has approved the supplemental request for the co-packaging of a convenience administration kit for Berinert (C1 esterase inhibitor, [Human]) for acute abdominal, facial, or laryngeal attacks of hereditary angioedema.
Berotralstat may reduce the use of on-demand medications in patients with hereditary angioedema (HAE) who were previously treated with prophylactic therapies.
A single dose of PHA-022121, an oral beta-2 antagonist, was associated with effective bradykinin-inhibiting concentrations within 15 minutes of administration in patients with hereditary angioedema.
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The oral, once-daily treatment will be shipped to patients with a prescription by specialty pharmacy Optime Care, Inc.
Orladeyo works by binding to plasma kallikrein and inhibiting its proteolytic activity.
Lanadelumab was effective for reducing hereditary angioedema attacks at up to 30 weeks of treatment, suggesting the monoclonal antibody is associated with sustained long-term efficacy.
Patients with hereditary angioedema taking berotralstat prophylactically had improved quality of life.
The expanded approval was based on data from the pivotal phase 3 COMPACT study and the COMPACT open-label extension study.
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.
