BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the European Commission (EC) has approved oral, once-daily ORLADEYO™ (berotralstat) for the prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older.
“As the first targeted oral prophylactic therapy approved in Europe, ORLADEYO represents a major advance in treatment for HAE patients who have been waiting for a preventive therapy. Physicians will be delighted to discuss this new option with their patients,” said Emel Aygören-Pürsün, M.D., head of the HAE Center at the University Hospital in Frankfurt.
“ORLADEYO offers people with HAE in Europe and their physicians the first orally administered non-steroidal option for preventing HAE attacks and represents a vitally important and most welcome step in making more treatment options available,” said Henrik Balle Boysen, executive vice president and chief operating officer of HAE International, a global non-profit network of patient associations dedicated to improving the lives of people with HAE.
The EC approval of ORLADEYO is applicable to all European Union member states plus Iceland, Norway and Liechtenstein.
https://finance.yahoo.com/news/biocryst-receives-european-commission-approval-132200808.html
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