Orladeyo FDA Approval History
FDA Approved: Yes (First approved December 3, 2020)
Brand name: Orladeyo
Generic name: berotralstat
Dosage form: Capsules
Company: BioCryst Pharmaceuticals, Inc.
Treatment for: Hereditary Angioedema
Orladeyo (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and
pediatric patients 12 years and older.
Development Timeline for Orladeyo
|Dec 3, 2020||ApprovalFDA Approves Orladeyo (berotralstat) as the First Oral, Once-Daily Therapy to Prevent Attacks in Hereditary Angioedema Patients|
|Feb 18, 2020||FDA Accepts BioCryst’s NDA for Oral, Once Daily Berotralstat (BCX7353) to Prevent HAE Attacks|
|Dec 11, 2019||BioCryst Submits New Drug Application for Oral, Once Daily Berotralstat (BCX7353) to Prevent HAE Attacks|
|May 21, 2019||BioCryst’s Oral BCX7353 Meets Primary Endpoint in Phase 3 APeX-2 Trial|
|Feb 23, 2019||BioCryst Reports ZENITH-1 Results With Oral BCX7353 Which Confirm Rapid Onset of Action, Sustained Activity and Robust Dose Response for Treatment of Acute HAE Attacks|
|Nov 16, 2018||BioCryst Presents Data Highlighting the Rapid and Sustained Plasma Concentrations of BCX7353 in HAE Patients at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology|
|Sep 4, 2018||BioCryst Reports Positive Results Across Multiple Endpoints in ZENITH-1 Trial of Oral BCX7353 as Acute Therapy for Hereditary Angioedema (HAE) Attacks|
|Aug 6, 2018||U.S. FDA Grants Fast Track Designation for BioCryst’s BCX7353|
|Jul 25, 2018||BioCryst Announces Publication of APeX-1 Clinical Trial Results for BCX7353 in The New England Journal of Medicine|
|Mar 15, 2018||BioCryst Announces Initiation of the Phase 3 APeX-2 Trial of BCX7353 in Patients with Hereditary Angioedema|
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