Cidara Therapeutics, of San Diego, announced today that the US Food and Drug Administration (FDA) has granted fast-track designation for CD388, the company's novel drug for preventing influenza A and B in adults at high risk for severe influenza, including those for whom vaccines are either ineffective or not indicated.
Fast-track designation aims to facilitate the development and expedite the review of drugs to treat serious conditions with unmet medical needs. The purpose is to get key new drugs to patients earlier. Companies that are granted this designation are given the opportunity for more frequent interactions with the FDA, and, if relevant criteria are met, eligibility for Priority Review.
Cidara is developing CD388, a drug-Fc conjugate candidate, in collaboration with Janssen Pharmaceuticals.
"We are pleased that the FDA has granted Fast Track designation for CD388, which emphasizes the unmet need for effective new prevention options for the many individuals who are not adequately protected by available influenza vaccines," said Jeffrey Stein, PhD, Cidara president and CEO.
[The approval] emphasizes the unmet need for effective new prevention options for the many individuals who are not adequately protected by available influenza vaccines.
Cidara recently announced promising interim efficacy and safety data from an ongoing phase 2a study being conducted in cooperation with Janssen. The study is evaluating how well CD388 prevents infection from the influenza A H3N2 strain.