- The Saudi Food and Drug Authority (SFDA) approved BioCryst Pharmaceuticals' ( NASDAQ: BCRX ) oral medicine Orladeyo (berotralstat) to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older.
- In September 2021, BioCryst signed a distribution agreement with Dubai-based NewBridge Pharmaceuticals, which also covers the Gulf Cooperation Council (GCC) and Iraq.
- "This marks the second market in the MENA region in which ORLADEYO has been approved for patients living with HAE, building on the approval in the UAE last year," said NewBridge President and CEO Joe Henein.
- The drug is already approved in the U.S. , Canada , and Switzerland among other places.
- HAE is a disorder characterized by recurrent episodes (attacks) of severe swelling of the skin and mucous membranes.
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BioCryst Orladeyo gets approval in Saudi Arabia to prevent hereditary angioedema attacks