Pint Pharma has announced the approval in Peru of Orladeyo (berotralstat) for use as an oral therapy to prevent hereditary angioedema (HAE) attacks.

Orladeyo is a product of BioCryst Pharmaceuticals. Pint Pharma owns its registration, marketing and distribution rights in Latin America (LATAM).

Approved by Peru’s General Directorate of Medicines, Supplies and Drugs, it is intended for the prophylaxis of HAE attacks in adults and children aged 12 and above.

Hereditary angioedema is a genetic disorder. It results in recurrent episodes of painful swelling of the mucous membranes, skin and submucosal tissues.

Pint Pharma scientific director Dr Valnei Canutti stated: “The approval of Orladeyo by DIGEMID is excellent news for the community of patients with hereditary angioedema in Peru.

“This innovative oral therapy represents a breakthrough for those living with this rare condition, offering an effective and convenient long-term prophylaxis option, preventing hereditary angioedema 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.

The once-daily oral capsule has been primarily developed to prevent HAE attacks by inhibiting plasma kallikrein activity.

Pint Pharma CEO David Muñoz stated: “Besides providing direct benefits to patients, the availability of Orladeyo in Peru highlights our continuous commitment to the advancement of research and innovation in the field of medical care for rare diseases.”

Pint Pharma LATAM North Cluster general manager Mauricio Botero stated: “The approval of Orladeyo is a great achievement for patients and proof of the successful collaboration among the medical community, regulators, and pharmaceutical companies in Peru to improve treatment options.”

In 2023, BioCryst secured marketing authorisation from the Public Health Institute of Chile for ORLADEYO.