Berotralstat, sold under the brand name Orladeyo, is a medication used to prevent attacks of hereditary angioedema (HAE) in people aged twelve years and older.[3][5][7][8][4]
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| Trade names | Orladeyo |
| Other names | BCX7353, BCX-7353 |
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| Routes of administration | By mouth |
| Drug class | Plasma kallikrein inhibitor |
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| Formula | C30H26F4N6O |
| Molar mass | 562.573 g·mol−1 |
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The most common side effects include abdominal pain, vomiting, diarrhea, back pain, and heartburn.[4]
Berotralstat was approved for medical use in the United States in December 2020,[3][4][9] and in the European Union in April 2021.[5]
History
Berotralstat was approved based on evidence from one clinical trial (Trial 1 /NCT03485911) of 120 participants with hereditary angioedema.[4] The trial was conducted at 40 sites in the United States, the European Union, and Canada.[4] Trial investigators evaluated participants 12 years and older[10] with hereditary angioedema for eight weeks to determine the number of attacks for each participant.[4] The trial enrolled only participants who had at least two attacks during the eight-week period.[4] Participants were assigned to receive one of two doses of berotralstat or placebo once every day for 24 weeks.[4] Neither the participants nor the investigators knew which treatment was being given until after the trial was completed.[4] All participants could use other medications for treatment of attacks.[4]
References
External links
- "Berotralstat". Drug Information Portal. U.S. National Library of Medicine.
- Clinical trial number NCT03485911 for "Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE (APeX-2)" at ClinicalTrials.gov
