BioCryst Expands Access to ORLADEYO® for HAE Patients

BioCryst Pharmaceuticals Introduces ORLADEYO in Portugal

In a significant boost for the treatment of hereditary angioedema (HAE), BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announces its ORLADEYO® (berotralstat) has been recommended by Infarmed for routine prevention in eligible patients aged 12 and older. This groundbreaking therapy is the first oral option that can be taken once daily, allowing patients to effectively manage their conditions.

A Landmark Moment for HAE Patients

Charlie Gayer, the Chief Commercial Officer at BioCryst, expressed optimism about this recommendation. He believes it empowers healthcare providers with better treatment options and promises an improved quality of life for patients living with HAE in Portugal. The journey to this recommendation was set in motion by the European Commission's marketing authorization for ORLADEYO in April. Since then, ORLADEYO has successfully launched in 44 countries, providing hope and relief to those affected by HAE.

Understanding ORLADEYO and its Mechanism

ORLADEYO works as a plasma kallikrein inhibitor, aimed at preventing recurrent HAE attacks among a diverse patient demographic. For those aged 12 years and older, this once-daily capsule significantly reduces the frequency of HAE attacks by targeting plasma kallikrein activity. The innovative design offers invaluable support to both adult and pediatric patients.

Indications and Safety Information

This medication is strictly for prophylaxis and not meant for treating acute HAE attacks. As effective as ORLADEYO is, it’s crucial to note that dosages over 150 mg daily are linked to QT prolongation, raising safety concerns. Common adverse reactions may include abdominal pain, vomiting, diarrhea, and back pain, affecting the overall user experience.

Dosage Considerations and Precautions

For patients with moderate or severe hepatic impairment, a reduced dosage of 110 mg daily with food is recommended. The utilization of certain medications along with ORLADEYO, specifically P-glycoprotein inducers or substrates, mandates careful monitoring due to possible interaction risks. Due to the absence of sufficient data, the use of ORLADEYO in patients under the age of 12, pregnant women, and breastfeeding is not advised without professional consultation.

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals stands at the forefront of biotechnology, emphasizing the treatment of rare diseases, particularly HAE. Through advanced drug design and innovative research, they develop therapies that promise to revolutionize patient care and improve quality of life. Their commitment to enhancing the health and well-being of individuals with challenging health conditions underlines their mission.

Contact Information for BioCryst

For inquiries about ORLADEYO and potential side effects, patients and healthcare professionals can reach out to:

John Bluth
+1 919 859 7910
jbluth@biocryst.com

Niamh Lyons
+353 87 639 7083
nlyons@biocryst.com

Frequently Asked Questions

What does ORLADEYO treat?

ORLADEYO is used for the routine prevention of recurrent attacks of hereditary angioedema in patients aged 12 and older.

How does ORLADEYO work?

This oral therapy inhibits plasma kallikrein, which is involved in the regulation of blood plasma, thereby preventing HAE attacks.

What are the common side effects of ORLADEYO?

Common side effects may include abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.

Is there a recommended dosage for patients with liver problems?

Yes, for patients with moderate or severe hepatic impairment, a dosage of 110 mg taken daily with food is recommended.

Where can I find more information about BioCryst Pharmaceuticals?

More information can be found on the official BioCryst Pharmaceuticals website.

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