FDA Approves Biomarker to Detect Infection for Trial Eligibility

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By Jeannie Baumann

Nov. 12 — A new biomarker to detect an infection caused by a common mold has been approved by the FDA for enrolling patients into drug studies, according to a guidance released Nov. 13.

The Food and Drug Administration's document, “Guidance on Qualification of Biomarker—Galactomannan in Studies of Treatments of Invasive Aspergillosis,” finalizes a draft guidance issued more than a year ago (79 Fed. Reg. 63,921, Oct. 27, 2014).

Janet Woodcock, director of the FDA's drug center, has said there's a need to develop evidentiary standards for biomarkers that can be integrated into drug development. The development of more qualifying biomarkers will be especially critical for precision medicine, which uses biomarkers to determine which patients are more likely to benefit from these targeted treatments.

With the guidance, drug developers can use the biomarker for “context of use,” an FDA term for a statement that describes “the manner of use, interpretation, and purpose of use of a biomarker in drug development.” Drug companies can now submit investigational new drug applications, new drug applications and biologics license applications without the FDA's Center for Drug Evaluation and Research having to review the biomarker to reconsider and reconfirm its suitability every time.

According to a Nov. 13 Federal Register notice announcing its availability (80 Fed. Reg. 70,235), the guidance provides a “qualified context of use (COU) for Galactomannan detection in serum and/or bronchoalveolar lavage (BAL) fluid as the sole microbiological criterion to classify patients as having probable invasive Aspergillosis (IA) for enrollment in clinical trials.”

The guidance also describes the conditions and constraints for which CDER determined this biomarker was acceptable under the agency's biomarker qualification program.

According to the Centers for Disease Control and Prevention, aspergillosis is caused by a common mold that can cause health problems in people with weakened immune systems or lung diseases, such as allergic reactions, lung infections and infections in other organs. Galactomannan is a molecule found in the cell wall of aspergillus species, Mayo Medical Laboratories explained.

The FDA approved a qualified infectious disease product designation—an expedited drug approval mechanism—in August for an antifungal drug to treat invasive aspergillosis.

Submit comments by Jan. 12, 2016, electronically to http://www.regulations.gov or in writing to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md. 20852. All comments should included Docket No. FDA-2013-D-1630.

For more information, contact Marianne Noone, Center for Drug Evaluation and Research (Office of Translational Sciences, Immediate Office), Food and Drug Administration, 10903 New Hampshire Ave., Building 21, Room 4528, Silver Spring, Md. 20993-0002, (301) 796-2600.

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bna.com

To contact the editor responsible for this story: Lee Barnes at lbarnes@bna.com

The guidance is available at http://src.bna.com/3w.

The Federal Register notice is at http://www.gpo.gov/fdsys/pkg/FR-2015-11-13/html/2015-28804.htm.

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