US FDA approves KalVista Pharma's swelling disorder drug
The regulator's greenlight comes after it extended the review of the drug, Ekterly, due to heavy workload and limited resources.
With the approval, Ekterly becomes the first on-demand oral treatment for hereditary angioedema, offering a convenient alternative to injectable treatments.
The life-threatening condition causes sudden, dangerous swelling in the body, including the skin, digestive tract and upper respiratory system, due to deficiency in a protein known as C1 inhibitor.
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