FDA Grants Orphan-Drug Exclusivity to Recorlev® for Endogenous Cushing's Syndrome Treatment

Xeris Pharmaceuticals has revealed that the FDA has awarded orphan-drug exclusivity for its drug Recorlev® (levoketoconazole) for treating adult patients with endogenous Cushing’s syndrome for whom surgery isn’t an option or has failed to cure the condition. Recorlev is the first approved treatment for this condition, giving Xeris seven years of exclusive market rights starting from its FDA approval on December 30, 2021.

Publish Date: 01-02-2023 Source: Xeris Pharmaceuticals

Endogenous Cushing’s syndrome (CS) is a rare, serious endocrine disorder caused by chronic exposure to the overproduction of cortisol. Because of the ubiquitous downstream effects of cortisol, chronic hypercortisolism leads to multisystem morbidities, including changes in physical appearance, cardiovascular complications (hypertension, venous thromboembolism, peripheral edema), metabolic disturbances (insulin resistance with impaired glucose tolerance), skeletal damage (osteopenia, osteoporosis, skeletal fractures), impairment of reproductive and sexual function (hypogonadism, menstrual irregularities, decreased libido, infertility), and neuropsychiatric disorders. Endogenous CS results from chronic exposure to excess cortisol because of adrenocorticotrophic hormone (ACTH)– dependent or ACTH-independent etiologies. ACTH-dependent CS accounts for 80–85% of overt CS cases; approximately 80–90% of these are attributed to Cushing’s disease (CD; ACTH-producing pituitary adenoma), and the rest result from extrapituitary neuroendocrine tumors causing ectopic ACTH production. ACTH-independent CS (15–20% of CS cases) results from autonomous adrenal overproduction of cortisol because of an adrenal adenoma, carcinoma, or bilateral hyperplasia.

The incidence of Endogenous Cushing’s syndrome (CS) varies between 2.4 to 3.2 cases per one million population.

However, the current Endogenous Cushing’s Syndrome (CS) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Metyrapone, Levoketoconazole, Relacorilant etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Endogenous Cushing’s Syndrome (CS) treatment. The key companies in the advanced development stage are HRA Pharma, Cortendo AB, Corcept Therapeutics, etc.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Endogenous Cushing’s Syndrome (CS) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

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