FDA Announces the Availability of a Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins

FDA Announces the Availability of a Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins

On August 10, 2020, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled “Drug-Drug Interaction Assessment for Therapeutic Proteins.” This draft guidance helps sponsors of investigational new drugs (INDs) and applicants of biologic license applications (BLAs) determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing a systematic, risk-based approach.

Therapeutic proteins are defined as proteins that are licensed as therapeutic biological products under section 351 of the Public Health Service Act (42 U.S.C 262). This guidance describes considerations for assessing DDIs between a therapeutic protein and small molecules or between therapeutic proteins, the types of DDI assessments and design considerations, and labeling recommendations. The guidance emphasizes consideration of the mechanisms of a potential DDI, taking into account the pharmacology and clearance of the therapeutic protein as well as co-administered medications in the patient population, and includes examples of the types of situations in which an assessment of the DDI potential of a therapeutic protein can be warranted. This guidance supplements the final FDA guidances entitled “In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions” (https://go.usa.gov/xfvrU) and “Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions,” (https://go.usa.gov/xfvrw) published in January 2020. 

The “Drug-Drug Interaction Assessment for Therapeutic Proteins” guidance is available at https://go.usa.gov/xfwDw. Please refer to the draft guidance for more details. FDA is publishing this draft guidance to collect additional public comments. You may submit your comments regarding the draft guidance to the docket (Docket No. FDA-2020-D-1480) available at https://www.regulations.gov up to 90 days following publication in the FEDERAL REGISTER. This draft guidance, when finalized, will represent the current thinking of the FDA on this topic.  It does not establish any rights for any person and is not binding on FDA or the public. Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience and make your voice count.

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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.