KalVista's Hereditary Angioedema Trial On Hold as FDA Requests Additional Data

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on KalVista Pharmaceuticals’ proposed Phase II trial of KVD824, a prophylactic treatment of hereditary angioedema. The agency is requesting additional information and analysis of preclinical studies regarding KVD824 before giving the go-ahead to the Phase II trial. In a letter sent to KalVista, the FDA adds that the clinical-stage pharmaceutical company needs to refine the study’s protocol.
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