FDA finalizes guidance on developing fixed combination hypertension drugs
FDA said Tuesday it has finalized guidance for developing fixed-combination medicines for the treatment of hypertension. A draft version of the guidance was released in January.
FDA said Tuesday it has finalized guidance for developing fixed-combination medicines for the treatment of hypertension. A draft version of the guidance was released in January. "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 wrote. The guidance focused on two-drug combinations; however, FDA said the approach detailed in the guidance "is readily applicable to three or more drugs in combination." It does not include combinations using investigational drugs. FDA said that when considering which drugs to use in a fixed combination, sponsors should opt for products "with reasonably distinct mechanisms of action" as they are likely to have additive effects compared with two drugs with similar mechanisms of action. In addition, FDA said it would anticipate seeing lower adverse effects for combinations that include doses below each drug products' maximum dose compared with single drug regimens at their top dose.