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How effective is Orladeyo?

Medically reviewed by Kristianne Hannemann, PharmD. Last updated on March 31, 2025.

Official Answer by Drugs.com

Clinical studies show that Orladeyo (berotralstat) effectively reduces hereditary angioedema (HAE) attacks:

How Does Orladeyo Work?

Orlando is a plasma kallikrein inhibitor that helps prevent hereditary angioedema (HAE) attacks in people 12 years and older. It works by:

Is Orladeyo FDA-Approved?

Yes, Orlando is an FDA-approved medication. The U.S. Food and Drug Administration (FDA) approved it on December 3, 2020, based on a 24-week clinical trial involving 120 adults and teens.

Orladeyo is not known to be safe or effective in children under 12 years old.

This is not all the information you need to know about Orladeyo (berotralstat) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

References

BioCryst. 2024. Why Orladeyo? Accessed 10/23/2024 at https://orladeyo.com/hae-treatment

Orladeyo [package insert]. Updated November 2023. BioCryst Pharmaceuticals Inc. Accessed 10/23/2024 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3527ece1-e7e0-40b1-b0c5-6baeb0deabeb

U.S. Food and Drug Administration. 2020. Drug Trials Snapshot: Orladeyo. Accessed 10/23/2024 at https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-orladeyo

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