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Orladeyo FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

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, 2020Approval FDA Approves Orladeyo (berotralstat) as the First Oral, Once-Daily Therapy to Prevent Attacks in Hereditary Angioedema Patients
Feb 18, 2020FDA Accepts BioCryst’s NDA for Oral, Once Daily Berotralstat (BCX7353) to Prevent HAE Attacks
Dec 11, 2019BioCryst Submits New Drug Application for Oral, Once Daily Berotralstat (BCX7353) to Prevent HAE Attacks
May 21, 2019BioCryst’s Oral BCX7353 Meets Primary Endpoint in Phase 3 APeX-2 Trial
Feb 23, 2019BioCryst 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, 2018BioCryst 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, 2018BioCryst Reports Positive Results Across Multiple Endpoints in ZENITH-1 Trial of Oral BCX7353 as Acute Therapy for Hereditary Angioedema (HAE) Attacks
Aug  6, 2018U.S. FDA Grants Fast Track Designation for BioCryst’s BCX7353
Jul 25, 2018BioCryst Announces Publication of APeX-1 Clinical Trial Results for BCX7353 in The New England Journal of Medicine
Mar 15, 2018BioCryst Announces Initiation of the Phase 3 APeX-2 Trial of BCX7353 in Patients with Hereditary Angioedema

Further information

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