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FDA Approves BioCryst's Hereditary Angioedema Drug - Japan & Europe Next?

fdaaprovedim sep19 03dec20 lt

The FDA has approved BioCryst Pharmaceuticals Inc.'s (BCRX) oral, once-daily ORLADEYO (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years and older.

Hereditary angioedema (HAE) is a rare disease characterized by unpredictable, potentially life-threatening recurrent swelling attacks most commonly affecting the extremities, face, abdomen, and larynx.

There are already 7 FDA-approved drugs for preventing and treating HAE attacks and all these drugs are delivered intravenously or administered subcutaneously. Berinert, Firazyr, Kalbitor and Ruconest are approved for treating HAE attacks while Cinryze, Haegarda, and Takhzyro are approved for preventing HAE attacks. (Source: US HAEA).

Orladeyo becomes the first oral treatment for preventing Hereditary Angioedema attacks. This drug is also under review in Japan and Europe, with a decision expected this month and March, respectively.

The company expects Orladeyo to achieve global peak sales of greater than $500 million.

Physicians can begin writing prescriptions for Orladeyo immediately, with direct to patient shipments from Optime Care expected to begin by the end of this month, the company added. Optime Care is he exclusive specialty pharmacy provider for Orladeyo.

BCRX closed Thursday's trading at $5.14, up 1.88%.

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