ORLADEYO is recommended to be taken once a day to prevent HAE attacks. Credit: Christina Victoria Craft on Unsplash.

BioCryst Pharmaceuticals has secured marketing authorisation from the Public Health Institute (ISP) of Chile for oral, once-daily ORLADEYO (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) attacks in patients aged 12 years and above.

ORLADEYO is an oral therapy that has been primarily developed to prevent HAE attacks by inhibiting plasma kallikrein activity.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The safety and effectiveness of the drug prophylaxis for acute HAE attacks are yet to be proved.

Extra doses of ORLADEYO above 150mg once daily are not suggested as this could lead to prolongation of the QT [a measure of the heart’s electrical activity].

BioCryst chief commercial officer Charlie Gayer stated: “Today’s announcement marks the first approval of ORLADEYO in Latin America, which is an important step forward in addressing the significant unmet needs of hereditary angioedema patients who live in the region.

“With this approval, we continue our mission to bring ORLADEYO to patients around the world who could benefit from an oral, once-daily prophylactic treatment option to improve control of their HAE attacks.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

In June 2022, BioCryst signed an exclusive partnership with Austrian company Pint Pharma to register and promote ORLADEYO across Latin America.

Pint is responsible for securing and maintaining marketing authorisations, as well as the commercialisation of the drug in Latin America.

In January 2022, BioCryst announced a partnership with Swixx BioPharma to commercialise Orladeyo in central and eastern Europe.