Xeris Biopharma gets USFDA approval for Endogenous Hypercortisolemia drug Recorlev

"Levoketoconazole (Recorlev) is an important and welcome new therapeutic option for clinicians to help manage patients with endogenous Cushing's syndrome, a severe, potentially life-threatening rare disease, if not appropriately treated, with multisystem signs and symptoms," said Maria Fleseriu, M.D., FACE, professor of Medicine and Neurological Surgery and director of the Pituitary Center at Oregon Health Sciences University. "In prospective clinical studies, treatment with levoketoconazole was shown to be effective for reducing and normalizing cortisol."

"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," said Leslie Edwin, president of the Cushing's Support & Research Foundation. "We are excited to see that the long and complicated path of rare drug development has reached FDA approval on a new therapeutic option for our underserved Cushing's community. We are grateful that the researchers worked so diligently for so long to establish the safety and efficacy of this drug. Rare disease patients know the importance of sharing their complicated experiences as 'expert witnesses', and we thank Xeris for being an early adherent to this concept. We especially want to thank the clinical trial patients who made this progress possible."

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