BioCryst's ORLADEYO Gains Full EU Reimbursement Approval With Netherlands Inclusion

(RTTNews) - BioCryst Pharmaceuticals (BCRX) announced that ORLADEYO (berotralstat) has been approved for national reimbursement in the Netherlands for routine prevention of hereditary angioedema (HAE) attacks in patients aged 12 and above.

This milestone means ORLADEYO now has reimbursement coverage in all major European countries, offering the first oral, once-daily preventive treatment for HAE.

Abid Karim, BioCryst's European general manager, stated that this marks a significant achievement in expanding patient access across Europe. ORLADEYO received European Commission marketing authorization in April 2021 and is now available in over 30 countries.

ORLADEYO is a plasma kallikrein inhibitor designed for daily use to prevent HAE attacks. It is not approved for acute treatment and higher doses may cause QT prolongation. Common side effects include gastrointestinal symptoms and back pain. Dosage adjustments are advised in patients with hepatic impairment, and caution is required with drug interactions involving P-gp and CYP enzymes. ORLADEYO's safety in patients under 12, pregnant, or breastfeeding individuals is not yet established.

Thursday, BCRX closed at $11.04, up 0.55%, and edged higher after hours to $11.05, up 0.09%, on the NasdaqGS.