ORLADEYO approved in Peru for HAE prevention

Pint Pharma has announced the approval of Orladeyo (berotralstat) in Peru, marking a significant advancement in the treatment of hereditary angioedema (HAE). Developed by BioCryst Pharmaceuticals, Orladeyo is designed as a once-daily oral capsule to prevent HAE attacks. Pint Pharma holds the rights for registration, marketing, and distribution of this drug in Latin America.

The approval by Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) allows the use of Orladeyo for the prophylactic treatment of HAE in adults and children aged 12 and above. Hereditary angioedema is a genetic disorder characterized by recurrent, often painful, swelling episodes affecting the mucous membranes, skin, and submucosal tissues.

Dr. Valnei Canutti, the scientific director at Pint Pharma, emphasized the significance of this approval for HAE patients in Peru. He remarked that Orladeyo represents a major breakthrough for individuals living with this rare condition, offering an effective and convenient long-term prophylaxis option to prevent HAE attacks.

Orladeyo works by inhibiting plasma kallikrein activity, which plays a crucial role in the onset of HAE attacks. The introduction of this drug is expected to dramatically improve the quality of life for those affected by HAE, providing a reliable and easy-to-administer treatment option.

David Muñoz, the CEO of Pint Pharma, highlighted the broader implications of Orladeyo’s availability in Peru. He noted that this approval not only benefits patients directly but also underscores Pint Pharma’s ongoing commitment to advancing research and innovation in the treatment of rare diseases.

Meanwhile, Mauricio Botero, the general manager of Pint Pharma’s LATAM North Cluster, described the approval as a considerable achievement for patients and a testament to the successful collaboration between the medical community, regulatory authorities, and pharmaceutical companies in Peru. He emphasized that such partnerships are vital for improving treatment options and healthcare outcomes for patients with rare conditions.

In addition to its approval in Peru, BioCryst Pharmaceuticals also secured marketing authorization for Orladeyo from the Public Health Institute of Chile in 2023. This further extends the availability of the drug within Latin America, ensuring more patients across the region gain access to this innovative treatment.

Overall, the approval of Orladeyo in Peru marks a noteworthy milestone in the management of hereditary angioedema, offering new hope and improved quality of life for patients struggling with this rare genetic disorder.