Strongbridge Biopharma Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for RECORLEV® for the Treatment of Endogenous Cushing’s Syndrome

FDA has accepted the filing of the RECORLEV® (levoketoconazole) New Drug Application. Strongbridge Biopharma believes that this decision reflects the extensive clinical evidence in the NDA submission, including positive and statistically significant efficacy and safety results from the multinational Phase 3 SONICS and LOGICS studies considering RECORLEV as a potential treatment option for adults with endogenous Cushing’s Syndrome (CS).

Publish Date: 13-05-2021   Source: Strongbridge Biopharma plc

Endogenous Cushing’s syndrome (CS) is a rare, severe 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 Cushing’s syndrome 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). The rest result from extra pituitary 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 treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Levoketoconazole Relacorilant, Metyrapone, Osilodrostat, AZD4017, Pasireotide) 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 Endogenous Cushing’s syndrome treatment. The key companies in the advanced development stage are AstraZeneca, Cortendo, HRA Pharma, Novartis, etc.. targeting CS.

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