New FDA Guidance Clears a Path for Urinary Infection Drugs of the Future
Posted 16 February 2015 | By
US healthcare product regulators have finalized a new policy set to make it easier for pharmaceutical companies to develop drugs to treat complicated urinary tract infections (cUTIs).
The US Food and Drug Administration's (FDA) new guidance document, Complicated Urinary Tract Infections: Developing Drugs for Treatment, says the agency will accept either superiority or non-inferiority trials in support of a new drug application for a product intended to treat cUTIs.
A single, controlled trial supported by other evidence may be sufficient to obtain approval for a new drug, FDA explained—fewer than the two trials most often required of new drugs. In addition, FDA says it recommends a "preapproval safety database of 700 patients or more" to help assure regulators of the safety of the drug product.
The guidance calls for a primary efficacy endpoint of either resolution of the cUTI symptoms and no additional symptoms, or "demonstration that the bacterial pathogen found at trial entry is reduced to fewer than 104 CFU/mL on urine culture." Outcomes contrary to those listed above will be determined to be clinical or microbiological failures, FDA said.
The agency also wants trial sponsors to follow up with patients 21 to 28 days after the start of treatment to ensure symptoms have not returned.
Placebos are not appropriate for testing on cUTIs, FDA added.
The final guidance replaces FDA's earlier draft guidance on the same subject, which it published in February 2012.
Complicated Urinary Tract Infections: Developing Drugs for Treatment (FR)