Dec 31 (Reuters) – The U.S. Food and Drug Administration has declined to approve Corcept Therapeutics’ drug for the treatment of a rare hormonal disorder, the company said on Wednesday.
The company said the FDA could not arrive at a favorable benefit-risk assessment for its hormone-blocking treatment, known as relacorilant, without Corcept providing additional evidence of effectiveness.
“We will meet with the FDA as soon as possible to discuss the best path forward,” said Joseph Belanoff, Corcept’s CEO.
The company was testing relacorilant as a treatment for patients with hypertension secondary to hypercortisolism.
Hypercortisolism, also known as Cushing’s syndrome, occurs when the body is exposed to high cortisol activity.
(Reporting by Sahil Pandey and Sneha S K in Bengaluru; Editing by Shailesh Kuber)
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