The US Food and Drug Administration (FDA) on Tuesday finalized guidance on developing fixed-combination drugs to treat hypertension.
The guidance, which finalizes a draft version released in January, focuses on the clinical development of two-drug combinations of previously approved products and has been updated primarily for editorial changes.
According to FDA, most hypertension patients will require more than one drug to adequately control their blood pressure. While in the past physicians typically started a patient on a single drug and titrated up to a maximum dose before adding additional drugs to their regimen, current guidelines recommend starting patients on two drugs at less than their full doses.
“FDA recognizes the interest both in developing combinations of less than full doses of drug products with distinct mechanisms of action … that could be used as initial therapy; and providing a range of combinations that allow dose titration to attain adequate blood pressure control,” FDA writes.
While the guidance focuses on two-drug combinations, FDA says that the approach described in the guidance “is readily applicable to three or more drugs in combination,” but does not cover combinations that include investigational drugs…