The FDA has given a fast-track designation to a drug designed to prevent infection from both influenza A and B strains created by San Diego-based Cidara Therapeutics, according to a June 22 news release.
The novel drug, CD388, is being developed alongside Janssen Pharmaceuticals primarily for flu prevention in adults who are high risk as well as for individuals for whom flu vaccines "are either ineffective or contraindicated," the release states.
The FDA's decision could prove to be timely as early data from the flu season that is currently underway in the Southern Hemisphere is showing that both influenza A and B are both circulating.
The fast-track designation of the drug "emphasizes the unmet need for effective new prevention options for the many individuals who are not adequately protected by available influenza vaccines," Jeffrey Stein, PhD, president and CEO of Cidara said in the release. "Based on its compelling profile and the promising data generated to date, we believe CD388 has the potential to serve as a safe and effective option for these high-risk patient populations with limited options for protection against both seasonal and pandemic strains of influenza A and B."