FDA decision on relacorilant for Cushing’s expected by year’s end
Agency to review application for therapy's approval for endogenous Cushing's
The U.S. Food and Drug Administration (FDA) has accepted an application from Corcept Therapeutics seeking the approval of relacorilant as a treatment for people with endogenous Cushing’s syndrome.
A decision from the FDA is now expected by Dec. 30, according to the company.
“The FDA’s acceptance of our new drug application takes us another step closer to bringing relacorilant to patients with hypercortisolism,” Joseph Belanoff, MD, CEO of Corcept, said in a company press release.
Cushing’s syndrome encompasses several diseases driven by hypercortisolism, or excessively high levels of the hormone cortisol in the body. High cortisol levels can cause a wide range of symptoms, including weight gain, skin changes, and mental health issues, and set the stage for other health complications, such as diabetes and high blood pressure, to arise.
Endogenous Cushing’s syndrome specifically refers to forms of Cushing’s in which high cortisol levels stem from issues within the body itself, often a tumor, that ultimately lead to an overproduction of cortisol. Cushing’s disease is the most common form of endogenous Cushing’s syndrome. In that form of Cushing’s, cortisol production is caused by a tumor that arises in the brain’s pituitary gland.
Developer Corcept says decision on relacorilant is due by Dec. 30
In the body, cortisol exerts its effects by binding to specialized receptors on cells. Relacorilant is an oral medication that’s designed to selectively modulate the activity of these receptors, reducing the effects of cortisol and easing Cushing’s symptoms.
Corcept’s application seeking relacorilant’s approval, submitted at the end of last year, was based in part on data from a Phase 3 clinical trial dubbed GRACE (NCT03697109). That study tested relacorilant in people with Cushing’s who had diabetes or high blood pressure, with the results suggesting the therapy could help reduce blood pressure, lower blood sugar levels, and promote weight loss.
Relacorilant’s combination of efficacy and safety gives it the potential to become the new standard of care for patients struggling with the devastating impact of this disease.
The application also includes data from another Phase 3 clinical trial, GRADIENT (NCT04308590), as well as a Phase 2 study (NCT02804750) and an extension study (NCT03604198) that tracked long-term outcomes in patients who had completed other studies. Consistent with the findings from GRACE, data from the extension study indicated that relacorilant led to long-term reductions in blood pressure and blood sugar, while continuing to promote weight loss.
The therapy also was found to be well tolerated, according to the developer. Common side effects seen in the studies included pain, headache, swelling, and nausea.
“Relacorilant’s combination of efficacy and safety gives it the potential to become the new standard of care for patients struggling with the devastating impact of this disease,” Belanoff said.
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