Chemistry:Berotralstat
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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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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]
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
- ↑ "Summary Basis of Decision - Orladeyo". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00610&lang=en.
- ↑ https://pdf.hres.ca/dpd_pm/00066149.PDF [bare URL PDF]
- ↑ 3.0 3.1 3.2 "Orladeyo- berotralstat hydrochloride capsule". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3527ece1-e7e0-40b1-b0c5-6baeb0deabeb.
- ↑ 4.00 4.01 4.02 4.03 4.04 4.05 4.06 4.07 4.08 4.09 4.10 "Drug Trials Snapshot: Orladeyo". 3 December 2020. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-orladeyo.
This article incorporates text from this source, which is in the public domain.
- ↑ 5.0 5.1 5.2 "Orladeyo EPAR". 24 February 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/orladeyo.
- ↑ "Orladeyo Product information". https://ec.europa.eu/health/documents/community-register/html/h1544.htm.
- ↑ "Oral plasma kallikrein inhibitor BCX7353 for treatment of hereditary angioedema". Immunotherapy 11 (17): 1439–1444. December 2019. doi:10.2217/imt-2019-0128. PMID 31635497.
- ↑ "Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: A randomized, double-blind, placebo-controlled phase 3 trial". The Journal of Allergy and Clinical Immunology 148 (1): 164–172.e9. October 2020. doi:10.1016/j.jaci.2020.10.015. PMID 33098856.
- ↑ "Orladeyo: FDA-Approved Drugs". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=214094.
- ↑ "Berotralstat (Oral Route) Side Effects - Mayo Clinic". https://www.mayoclinic.org/drugs-supplements/berotralstat-oral-route/side-effects/drg-20506380?p=1.
External links
- "Berotralstat". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/berotralstat.
- 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
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