Peru Approves ORLADEYO® (berotralstat)

July 09, 2024 - BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) has announced that the General Directorate of Medicines, Supplies and Drugs (DIGEMID) in Peru has granted approval for ORLADEYO® (berotralstat). This oral, once-daily medication is intended for the prevention of hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older.

Charlie Gayer, the chief commercial officer of BioCryst, expressed excitement about this development, noting the collaboration with Pint Pharma to introduce ORLADEYO to patients requiring new treatment options across Latin America. With DIGEMID's approval, patients in Peru will have access to this prophylactic therapy soon.

BioCryst has an exclusive partnership with Pint Pharma GmbH to manage the registration and promotion of ORLADEYO throughout Latin America. According to the agreement, Pint is responsible for obtaining and maintaining marketing authorizations and commercializing ORLADEYO in the region. The drug has already received approval from regulatory bodies in Chile, Argentina, Brazil, and Mexico.

ORLADEYO (berotralstat) is a groundbreaking oral therapy designed specifically to prevent HAE attacks in adults and pediatric patients aged 12 years and older. The medication works by reducing the activity of plasma kallikrein, effectively preventing HAE episodes with just one capsule per day.

In the United States, ORLADEYO is indicated for the prophylaxis of hereditary angioedema attacks in adults and pediatric patients aged 12 and above. However, the efficacy of ORLADEYO for treating acute HAE attacks has not been established, and it is not recommended for that use. Higher dosages than the standard 150 mg once daily are discouraged because of the potential for QT prolongation, a heart rhythm condition.

The most common side effects reported in patients taking ORLADEYO include abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease. For patients with moderate or severe hepatic impairment, a reduced dosage of 110 mg taken once daily with food is recommended. 

ORLADEYO interacts with several other medications. For example, P-glycoprotein (P-gp) inducers like rifampin and St. John’s wort may decrease berotralstat plasma concentration, reducing the drug's efficacy. Therefore, using P-gp inducers alongside ORLADEYO is not recommended. Additionally, ORLADEYO at a dose of 150 mg acts as a moderate inhibitor of CYP2D6 and CYP3A4 enzymes, necessitating monitoring and dose adjustments for concomitant medications that are metabolized by these enzymes. At a dose of 300 mg, ORLADEYO inhibits P-gp, and similar monitoring is recommended for P-gp substrates such as digoxin.

The safety and effectiveness of ORLADEYO in children under 12 years of age have not been established. Moreover, there is insufficient data to determine the drug-related risks during pregnancy or its presence in human milk and effects on a breastfed infant.

BioCryst Pharmaceuticals is dedicated to improving the lives of individuals with complement-mediated and other rare diseases. The company employs its expertise in structure-guided drug design to develop innovative oral small-molecule and protein therapeutics. ORLADEYO is the first oral, once-daily plasma kallikrein inhibitor commercialized by BioCryst, and the company is also advancing a pipeline of other therapeutic candidates.

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