Therapeutic Protein Drug Interaction Assessment Guide

FDA has posted a final guidance entitled “Drug-Drug Interaction Assessment for Therapeutic Proteins.” The document is intended to help sponsors determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing recommendations for a systematic, risk-based approach. “Due to the evolving knowledge of novel products, sponsors should consult corresponding review divisions for detailed information regarding a specific DDI assessment,” the guidance says.

In general, it says that when evaluating the potential for a DDI between a therapeutic protein and small molecules or between therapeutic proteins, sponsors should consider factors such as the potential mechanism for the interaction, disease type and severity (if the DDI mechanism is related to the disease condition), biological product type, therapeutic protein clearance pathways, and commonly co-administered drugs in the proposed patient population.