How effective is Orladeyo?

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

• In a study with adults and teens, Orladeyo reduced monthly HAE attacks from 3.1 to 1.3 after six months of treatment. In comparison, those on a placebo saw a smaller reduction, from 2.9 to 2.4 attacks per month.
• Over two years, people taking Orladeyo 150 mg once daily experienced a 91% reduction in their HAE attack rate. Attacks decreased from 2.8 per month before treatment to 0.3 per month after two years.
• A decrease in HAE attacks was observed within the first month of treatment.

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:

• Blocking plasma kallikrein, a protein involved in the production of bradykinin, which causes swelling and pain.
• Reducing bradykinin levels, helping to prevent HAE attacks before they occur.

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.