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New Drugs Approved In December

Orladeyo
Orladeyo

The FDA approved Orladeyo (berotralstat), developed by BioCryst Pharmaceuticals Inc. (BCRX), on December 3, 2020, to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older.

Hereditary angioedema is a rare disease characterized by recurrent attacks of severe swelling in body parts including the limbs, face, intestinal tract, and airway.

Orladeyo is the first orally administered non-steroidal option for preventing HAE attacks.

BioCryst has priced the drug at $485,000 per patient per year.

Takeda’s Takhzyro, Shire's (a unit of Takeda), Cinryze and CSL Behring’s Haegarda are injectable drugs approved for preventing HAE attacks.

Orladeyo is under review in Europe with a decision expected in March.