BioCryst's Orladeyo Wins EU Positive Opinion For Hereditary Angioedema

The European Medicines Agency's Committee for Orphan Medicinal Products has issued a positive opinion backing the approval of BioCryst Pharmaceuticals Inc's (NASDAQ: BCRX) ORLADEYO (berotralstat) for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
HAE is a disorder characterized by recurrent attacks severe swelling (angioedema). The swelling most commonly affects the arms, legs, face, intestinal tract, and airway and is usually not itchy.
The European Commission will review the recommendation, and a final approval decision on the marketing application is expected in the second quarter.
The product is approved in the U.S. and Japan.
Early Access to the treatment has been approved by the Medicines & Healthcare products Regulatory Agency in the U.K.
Price Action: BCRX shares are trading 0.2% lower at $10.45 in the premarket session on the last check Friday.