RECORDATI SUBMITS NEW DRUG APPLICATION FOR ISTURISA IN JAPAN

RECORDATI SUBMITS NEW DRUG APPLICATION FOR ISTURISA IN JAPAN

Milan, 26 March 2020 – Recordati announces the submission of the Japanese New Drug Application (JNDA) to the Ministry of Health, Labour and Welfare seeking marketing approval for osilodrostat an oral inhibitor of 11-beta-hydroxylase for the treatment of patients with Cushing ‘s syndrome (CS).

 

The JNDA for osilodrostat is primarily based on data generated by the clinical program which included Japanese patients. In the Phase 3 LINC‐3 study, a significantly higher proportion of patients treated with Isturisa (osilodrostat) maintained normal mean urinary free cortisol (mUFC) at the end of the 8‐week randomized withdrawal period (week 34) versus placebo (86.1% vs 29.4%). The safety profile was manageable.

 

“We are excited about this regulatory filing for osilodrostat in Japan which, if approved, will provide a new and convenient oral treatment option that will help address patients’ needs in this underserved patient population” said Andrea Recordati, CEO.

 

About Cushing’s Syndrome

 

Cushing’s syndrome is a rare, chronically debilitating, life-threatening condition. The primary clinical symptoms of Cushing’s syndrome are due to hypercortisolism and include the following: changes in body habits due to increased fat accumulation; hirsutism; skin changes with easy bruising, purplish striae, reddening and ulceration of the cheeks; generalized weakness and fatigue; wasting of musculature; menstrual disorders in females; decreased fertility and/or libido; hypertension; weight gain; increased insulin resistance with alterations in glucose metabolism; dyslipidemia; depression, mood and behavior disorders; sleep disturbances and osteopenia/osteoporosis.

 

Hypercortisolism is the main driving force of morbidity and mortality in patients with Cushing’s syndrome, therefore, potent inhibition of cortisol synthesis (and the resulting normalization of cortisol levels) has the potential to ameliorate the complications of this debilitating group of disorders.

 

About Isturisa

 

Isturisa ( osilodrostat) is a cortisol synthesis inhibitor that works by preventing 11‐betahydroxylase, an enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland, from being created. Given the mechanism of action to inhibit cortisol synthesis at the adrenal glands, osilodrostat has therapeutic potential in all forms of endogenous Cushing syndrome.