Xeris Biopharma Holdings (NASDAQ:XERS) Inc revealed that the Food and Drug Administration (FDA) granted its subsidiary Xeris Pharmaceuticals Inc, orphan-drug exclusivity (ODE) for Recorlev (levoketoconazole) for the treatment of adult patients with endogenous Cushing’s syndrome, for whom surgery is not an option, or hasn’t worked.
Endogenous Cushing’s syndrome is a rare and potentially fatal endocrine disease caused by chronic elevated cortisol exposure, which is often the result of a benign tumor of the pituitary gland. The tumor tells the body to overproduce high levels of cortisol, which results in symptoms that are distressing to patients.
The Chicago-based biopharmaceutical company noted that because this is the first approval of levoketoconazole (Recorlev) for Cushing’s syndrome, Xeris is entitled to seven years of orphan-drug market exclusivity from its FDA approval date of December 30, 2021.
READ: Xeris Biopharma reveals Phase 3 SONICS study data evaluating Recorlev for Cushing's syndrome
The FDA's Orphan Drug program is designed to advance the development of drugs that treat a condition affecting 200,000, or fewer US patients annually. The exclusivity is in addition to the patent exclusivity under Xeris’ US patents covering Recorlev and its therapeutic use, which extends to at least March 2040, said the company.
“Cushing’s syndrome is a rare disease that can be physically and emotionally devastating to the patient. Most patients endure years of symptoms prior to obtaining a diagnosis and are then faced with limited effective treatment options," Xeris CEO Paul R Edick said in a statement.
“We are excited to receive this important orphan-drug exclusivity approval for Recorlev on a new therapeutic option that can address symptoms while treating the root cause of the disease for this underserved Cushing’s patient community.”
Positive Phase 3 studies
Edick noted that Recorlev offers an “important” therapeutic option to clinicians trying to manage patients with endogenous Cushing's syndrome.
“The approval of Recorlev was based upon data from two positive Phase 3 studies that evaluated a combined study population of 166 patients and was shown to be effective for reducing and normalizing cortisol,” added Edick.
To support this patient community, Xeris said it is “committed” to ensuring everyone who needs access to their therapies will receive it. Xeris has created Xeris CareConnection to provide a comprehensive program for patients and their caregivers, including financial assistance, one-on-one support, and educational resources.
Xeris CareConnection also supports healthcare professionals and their teams through education on access and reimbursement. One can get more information regarding the program at www.recorlev.com or by contacting Xeris CareConnection at 1-844-444-RCLV (7258).
Xeris has three commercially available products; Gvoke, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis, the first FDA-approved therapy for primary periodic paralysis, and Recorlev for the treatment of endogenous Cushing’s syndrome. It also has a diverse pipeline of development and partnered programs using its proprietary formulation technology platforms, XeriSol and XeriJect.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive