BioCryst Welcomes ORLADEYO's Approval in Colombia for HAE
ORLADEYO Gains Approval in Colombia
BioCryst Pharmaceuticals, Inc. has recently received exciting news regarding its innovative treatment, ORLADEYO (berotralstat). The National Institute of Drug and Food Surveillance in Colombia has officially approved this once-daily oral medication for the prevention of hereditary angioedema (HAE) attacks in both adults and children aged 12 years and older. This approval signifies a noteworthy progress in improving treatment options for individuals grappling with the challenges of HAE.
Expanding Access to Life-Changing Therapy
Charlie Gayer, the chief commercial officer of BioCryst, expressed enthusiasm about the approval, stating, "Today’s announcement marks another important step toward bringing ORLADEYO to people living with HAE who are in need of new treatment options across the pan-Latin America region." This comments highlights the company's commitment to expanding access to vital therapies and underscores the collaborative efforts with Pint Pharma to ensure that Colombian patients can benefit from this groundbreaking treatment.
The Collaboration with Pint Pharma
BioCryst's partnership with Pint Pharma GmbH is especially noteworthy as it reflects the strategic efforts being made to enhance the availability of ORLADEYO throughout Latin America. This collaboration entails that Pint Pharma will oversee obtaining and maintaining all necessary marketing authorizations to ensure ORLADEYO is successfully commercialized in the region. Previously, ORLADEYO has been granted approval in several other countries, including Chile, Argentina, Brazil, Mexico, and Peru, reflecting a growing recognition of its significance in the treatment landscape for HAE.
What Is ORLADEYO?
ORLADEYO (berotralstat) stands out as the first oral therapy specifically designed to prevent hereditary angioedema attacks in patients aged 12 years and older. The treatment works effectively with a single daily capsule, showing promise by decreasing plasma kallikrein activity, which is crucial in the pathology of HAE. This novel medication brings hope to patients looking for reliable prophylaxis against HAE attacks.
Health Considerations and Usage
Among the significant considerations for ORLADEYO is its indication as a plasma kallikrein inhibitor, aimed at preventing acute HAE attacks in the targeted demographic. However, it is important to note that the effectiveness of ORLADEYO for treating acute HAE attacks has not been proven, making it essential for patients to understand the proper use of this medication.
Safety Information
Some important safety information includes a warning regarding the potential for QT prolongation at dosages higher than the recommended 150 mg once daily. Common adverse reactions observed in patients treated with ORLADEYO include abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease. Patients with moderate or severe hepatic impairment may require a reduced dosage of 110 mg taken with food daily.
BioCryst emphasizes the need for monitoring when coadministering ORLADEYO with medications metabolized by CYP2D6 or CYP3A4 due to potential interactions that could alter the effectiveness of other therapies.
Commitment to Patient Care
BioCryst is deeply rooted in its mission to improve the lives of individuals suffering from hereditary angioedema and other rare diseases. The company employs its profound expertise in structure-guided drug design, aiming to create first-in-class therapeutics that address the complexities of these challenging medical conditions. Besides ORLADEYO, the company is actively advancing a diverse pipeline of innovative small-molecule and protein therapies.
Stay Informed and Connected
For those interested in learning more about ORLADEYO or BioCryst Pharmaceuticals, it is encouraged to visit their official website. Staying informed about the latest developments in treatments for hereditary angioedema can significantly benefit both patients and caregivers as they navigate their care options.
Frequently Asked Questions
What is ORLADEYO?
ORLADEYO is the first oral therapy designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Who is eligible for ORLADEYO treatment?
ORLADEYO is approved for adults and pediatric patients aged 12 years and older for the prevention of hereditary angioedema attacks.
How does ORLADEYO work?
ORLADEYO works by inhibiting plasma kallikrein, which plays a role in the development of HAE attacks.
What should patients consider before using ORLADEYO?
Patients should understand that ORLADEYO is not intended for the treatment of acute HAE attacks and must adhere to prescribed dosages to prevent potential side effects.
How can patients report adverse reactions?
Patients can report suspected adverse reactions directly to BioCryst Pharmaceuticals or the FDA for appropriate monitoring and response.
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