Saturday, July 13, 2024

DIGEMID Approves ORLADEYO for Hereditary Angioedema, Advancing Treatment in Peru

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Angioedema prophylaxis takes a step forward as the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) in Peru approves the daily oral use of ORLADEYO® (berotralstat) for hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older, announces Pint Pharma. This milestone marks a significant advancement in the treatment of HAE in Peru, providing patients with an innovative and effective option to manage their condition.

Hereditary angioedema is a genetic disorder that causes recurrent episodes of sudden and painful swelling of the skin, mucous membranes, and submucosal tissues. Until recently, treatment options for HAE were limited, leaving patients with a compromised quality of life and a constant risk of severe attacks. The approval of ORLADEYO by DIGEMID offers new hope for these patients, providing a convenient and effective long-term prophylaxis option.

Dr. Valnei Canutti, Chief Scientific Officer of Pint Pharma, emphasized the significance of this approval: “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.”

Pint Pharma Celebrates ORLADEYO Approval in Peru, Enhancing Treatment for Hereditary Angioedema

David Muñoz, CEO of Pint Pharma, highlighted the broader impact of this approval: “In addition to providing direct benefits to patients, the availability of ORLADEYO in Peru underscores our continued commitment to advancing research and innovation in the field of healthcare for rare diseases. This approval is a testament to our dedication to improving the lives of patients with rare conditions through cutting-edge medical solutions.”

Mauricio Botero, General Manager of Pint Pharma in the Latam North Cluster, echoed these sentiments: “The approval of ORLADEYO is a great achievement for patients and a testament to the successful collaboration between the medical community, regulators, and pharmaceutical companies in Peru to improve treatment options. This milestone showcases the positive outcomes that can be achieved through coordinated efforts in the healthcare sector.”

ORLADEYO® (berotralstat) is the first and only oral therapy specifically designed to prevent hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older. By reducing plasma kallikrein activity, a single daily ORLADEYO capsule effectively prevents HAE attacks, offering patients a much-needed prophylactic treatment. ORLADEYO is a product of BioCryst Pharmaceuticals, Inc., and its registration, marketing, and distribution are exclusively managed by Pint Pharma in Latin America.

Hereditary Angioedema

ORLADEYO Approval in Peru Marks Major Advancement in Hereditary Angioedema Treatment

The introduction of ORLADEYO in Peru represents a significant advancement in the management of hereditary angioedema. Patients previously faced limited treatment options, often leading to a diminished quality of life and constant anxiety over potential attacks. With the availability of this oral therapy, patients now have access to a more convenient and effective means of preventing HAE episodes, allowing them to lead more normal and less interrupted lives.

This approval also highlights the importance of continued investment in research and development within the field of rare diseases. Pint Pharma’s commitment to bringing innovative solutions to the market reflects a broader dedication to enhancing patient care and improving outcomes for those affected by rare conditions. The collaboration between medical professionals, regulatory bodies, and pharmaceutical companies is crucial in achieving these advancements and ensuring that patients receive the best possible care.

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In conclusion, the approval of ORLADEYO by DIGEMID is a landmark achievement for the treatment of hereditary angioedema in Peru. It not only provides a new and effective treatment option for patients but also signifies the ongoing efforts of Pint Pharma to lead the way in rare disease healthcare. This development promises to significantly improve the lives of those affected by HAE, offering them hope and a higher quality of life through better management of their condition.


Resource: Business Wire, July 08, 2024

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