Cidara Therapeutics receives U.S. FDA BTD for CD388

Cidara Therapeutics (CDTX) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy designation, BTD, for CD388 for prevention of influenza A and B in adults and adolescents who are at higher risk of influenza complications due to underlying immunodeficiency, are at higher risk of severe influenza despite influenza vaccination, or those for whom vaccines are contraindicated. “This Breakthrough Therapy designation, in addition to the previously awarded Fast Track designation, underscores the importance of CD388 as a potential new non-vaccine prophylactic for seasonal influenza,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Individuals who have chronic medical conditions, advanced age, or are immune compromised may not be adequately protected by current vaccines, leaving them at higher risk for infection and complications from flu. As a long-acting prophylactic drug, CD388’s activity does not rely on an immune response, making it a potential prevention option for high-risk individuals as well as those for whom vaccines are contraindicated. We look forward to advancing CD388 through our ongoing Phase 3 ANCHOR trial and submission of a Biologic License Application.”