Hypertension Drug Development: FDA Draft Guidance Outlines Recommendations
The US Food and Drug Administration (FDA) on Friday issued draft guidance providing recommendations for sponsors looking to develop drugs to treat hypertension in patients already taking several other antihypertensive medications.
FDA says the guidance was developed in response to requests from drugmakers who sought input from the agency on treating resistant hypertension, or hypertension that is "not adequately controlled by maximally tolerated doses of three or more antihypertensive drugs with different mechanisms of action.
"FDA encourages the development of additional classes of drugs for hypertension, particularly classes of drugs that demonstrate effects when added to currently available therapies," the agency writes.
Currently, all FDA-approved antihypertensive drugs are labeled for use alone or in combination with other antihypertensive drugs, as adding antihypertensive drugs with a different mechanism of action can result in a greater reduction of blood pressure.
Those drugs span different classes, including diuretics, renin-angiotensin system inhibitors, beta blockers, calcium channel blockers, aldosterone antagonists, alpha blockers, central alpha agonists and direct vasodilators.
Despite the wide array of products available for lowering blood pressure, FDA says drugs with novel mechanisms of action "would be valuable."
Guidance
For sponsors looking to develop antihypertensive drugs in patients taking three or more background antihypertensive treatments, FDA says there are at least two paths to gain approval, though the development path "is not fundamentally different from standard development of antihypertensive drugs."
One path would be to demonstrate superiority to a placebo in reducing blood pressure in patients taking three or more other antihypertensive drugs with different mechanisms of action.
FDA says this path would result in an indication to lower blood pressure, with information about the other medications and doses appearing in the Clinical Studies section of the labeling.
The other path would be to demonstrate superiority to one or more already approved anti-hypertensive drugs in patients taking maximum doses of at least three alternative therapies with different mechanisms of action.
This, FDA says, would result in a claim that the new drug is superior to the active comparator(s) in lowering blood pressure. Information about the background therapies would also be listed in the Clinical Studies section of the labeling for drugs approved through this development path.