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.
Posted In: European Commissionhereditary angioedemaBiotechNewsSmall CapFDAGeneral