Ionis Pharmaceuticals (IONS) said Monday the US Food and Drug Administration has accepted for review a new drug application for donidalorsen for prophylaxis to prevent attacks of hereditary angioedema in adults and patients 12 years of age and older.
The regulator has set an action date of Aug. 21, 2025, under the Prescription Drug User Fee Act, the company said.
Hereditary angioedema is a rare genetic disease that causes recurrent attacks of severe swelling in several parts of the body, Ionis said.
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