Post by icemandios on Jan 31, 2022 13:36:47 GMT
Xeris Biopharma Announces Recorlev® (levoketoconazole) Is Now Commercially Available for the Treatment of Endogenous Hypercortisolemia in Adult Patients With Cushing’s Syndrome
Recorlev ® (levoketoconazole) now exclusively available through PANTHERx Rare Specialty Pharmacy
To increase patient access to Recorlev, the Company has established Xeris CareConnection™, a comprehensive support program, which includes $0 co-pay for commercially insured patients, one-on-one support and education for patients, and reimbursement and access support.
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, today announced that Recorlev ® (levoketoconazole) is now available for prescription. The U.S. Food and Drug Administration (FDA) approved Recorlev on December 31, 2021 for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. 1
“The commercial availability of Recorlev represents a significant milestone for the Cushing’s syndrome community, particularly for people living with uncontrolled disease, who until now were faced with limited therapeutic options,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “Xeris is proud to introduce this meaningful new treatment option to patients in the U.S. and is focused on meeting the needs of the rare disease community by ensuring access to treatment and providing comprehensive patient and physician support services.”
Xeris has also partnered with PANTHERx Rare Specialty Pharmacy to provide a customized support and product distribution program, Xeris CareConnection™, for members of the Recorlev ecosystem, including patients, caregivers, physicians, and payors. Xeris CareConnection provides access to pharmacists, case managers and access managers, including white-glove services throughout the entire treatment journey. Patients will also receive welcome information, therapy onboarding, at-home delivery of medication, a discreet courier service for urinary free cortisol (UFC) test collection, automatic monthly refill shipments, financial assistance, one-on-one support, and ongoing educational resources. Xeris CareConnection also supports healthcare professionals and their teams through education on access and reimbursement. To get started with Recorlev, reach out to Xeris CareConnection (available Monday–Friday, 8 a.m.–7 p.m. ET) at 1-844-444-RCLV (7258).
“Endogenous Cushing’s syndrome (CS), a rare and potentially fatal endocrine disease caused by chronic, elevated cortisol exposure, affects women three times more often than men,” said Ken Johnson, Pharm.D., SVP, Global Development and Medical Affairs at Xeris. “Normalization of cortisol levels is the first and most important clinical objective in the treatment of Cushing’s syndrome and the approval of new medicines like Recorlev can aid physicians and patients to achieve this objective. Many of the symptoms of CS can significantly impact self-esteem, body image, and intimate relationships, therefore, it is exciting to now be able to offer patients suffering from this condition an effective oral treatment option.”
Xeris is committed to ensuring that everyone who needs access to their therapies will receive it. Consequently, Xeris has established a $0 co-pay program and Patient Assistance Program for eligible patients with financial hardship or limited or no insurance. For more information, please visit www.RECORLEV.com .
The FDA approval of Recorlev ® was based upon safety and efficacy data from two positive Phase 3 studies that evaluated a combined study population of 166 patients, which was representative of the adult drug-treated U.S. population with Cushing’s syndrome. 1 LOGICS, a double-blind, placebo-controlled randomized-withdrawal study met its key endpoint of normalizing and maintaining therapeutic response compared with placebo (detailed results here ). 1 The supportive SONICS study met its primary and key secondary endpoints, significantly reducing and normalizing mean urinary free cortisol concentrations without a dose increase (detailed results here ). 1,2
About Cushing’s Syndrome
Endogenous Cushing’s syndrome is a rare, serious, and potentially fatal endocrine disease caused by chronic elevated cortisol exposure—often the result of a benign tumor of the pituitary gland. This benign tumor tells the body to overproduce high levels of cortisol for a sustained period of time, which often results in characteristic physical signs and symptoms that are distressing to patients. The disease is most common among adults between the ages of 30–50, and it affects women three times more often than men. Women with Cushing's syndrome may experience a variety of health issues including menstrual problems, difficulty becoming pregnant, excess male hormones (androgens), primarily testosterone, which can cause hirsutism (growth of coarse body hair in a male pattern), oily skin, and acne. 3
Additionally, the multisystem complications of the disease are potentially life threatening. These include metabolic changes such as high blood sugar or diabetes, high blood pressure, high cholesterol, fragility of various tissues including blood vessels, skin, muscle, and bone, and psychological disturbances such as depression, anxiety, and insomnia. 3 Untreated, the five-year survival rate is only approximately 50%. 4
About Recorlev
Recorlev ® (levoketoconazole) is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. 1 Endogenous Cushing’s syndrome is a rare but serious and potentially fatal endocrine disease caused by chronic elevated cortisol exposure. 2 Recorlev is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor. 1 Recorlev has demonstrated in two successful Phase 3 studies to significantly reduce mean urinary free cortisol. 1
The Phase 3 program for Recorlev included LOGICS and SONICS, two multinational studies designed to evaluate the safety and efficacy of Recorlev when used to treat endogenous Cushing’s syndrome. LOGICS, a double-blind, placebo-controlled randomized-withdrawal study met its key endpoint of normalizing and maintaining therapeutic response compared with placebo (detailed results here ). 1 The supportive SONICS study met its primary and secondary endpoints, significantly reducing and normalizing mean urinary free cortisol concentrations without a dose increase. 1,2 The ongoing open-label OPTICS study will gather further useful information related to the long-term use of Recorlev.
Recorlev received orphan drug designation from the FDA and the European Medicines Agency for the treatment of endogenous Cushing's syndrome.
Recorlev ® (levoketoconazole) now exclusively available through PANTHERx Rare Specialty Pharmacy
To increase patient access to Recorlev, the Company has established Xeris CareConnection™, a comprehensive support program, which includes $0 co-pay for commercially insured patients, one-on-one support and education for patients, and reimbursement and access support.
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, today announced that Recorlev ® (levoketoconazole) is now available for prescription. The U.S. Food and Drug Administration (FDA) approved Recorlev on December 31, 2021 for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. 1
“The commercial availability of Recorlev represents a significant milestone for the Cushing’s syndrome community, particularly for people living with uncontrolled disease, who until now were faced with limited therapeutic options,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “Xeris is proud to introduce this meaningful new treatment option to patients in the U.S. and is focused on meeting the needs of the rare disease community by ensuring access to treatment and providing comprehensive patient and physician support services.”
Xeris has also partnered with PANTHERx Rare Specialty Pharmacy to provide a customized support and product distribution program, Xeris CareConnection™, for members of the Recorlev ecosystem, including patients, caregivers, physicians, and payors. Xeris CareConnection provides access to pharmacists, case managers and access managers, including white-glove services throughout the entire treatment journey. Patients will also receive welcome information, therapy onboarding, at-home delivery of medication, a discreet courier service for urinary free cortisol (UFC) test collection, automatic monthly refill shipments, financial assistance, one-on-one support, and ongoing educational resources. Xeris CareConnection also supports healthcare professionals and their teams through education on access and reimbursement. To get started with Recorlev, reach out to Xeris CareConnection (available Monday–Friday, 8 a.m.–7 p.m. ET) at 1-844-444-RCLV (7258).
“Endogenous Cushing’s syndrome (CS), a rare and potentially fatal endocrine disease caused by chronic, elevated cortisol exposure, affects women three times more often than men,” said Ken Johnson, Pharm.D., SVP, Global Development and Medical Affairs at Xeris. “Normalization of cortisol levels is the first and most important clinical objective in the treatment of Cushing’s syndrome and the approval of new medicines like Recorlev can aid physicians and patients to achieve this objective. Many of the symptoms of CS can significantly impact self-esteem, body image, and intimate relationships, therefore, it is exciting to now be able to offer patients suffering from this condition an effective oral treatment option.”
Xeris is committed to ensuring that everyone who needs access to their therapies will receive it. Consequently, Xeris has established a $0 co-pay program and Patient Assistance Program for eligible patients with financial hardship or limited or no insurance. For more information, please visit www.RECORLEV.com .
The FDA approval of Recorlev ® was based upon safety and efficacy data from two positive Phase 3 studies that evaluated a combined study population of 166 patients, which was representative of the adult drug-treated U.S. population with Cushing’s syndrome. 1 LOGICS, a double-blind, placebo-controlled randomized-withdrawal study met its key endpoint of normalizing and maintaining therapeutic response compared with placebo (detailed results here ). 1 The supportive SONICS study met its primary and key secondary endpoints, significantly reducing and normalizing mean urinary free cortisol concentrations without a dose increase (detailed results here ). 1,2
About Cushing’s Syndrome
Endogenous Cushing’s syndrome is a rare, serious, and potentially fatal endocrine disease caused by chronic elevated cortisol exposure—often the result of a benign tumor of the pituitary gland. This benign tumor tells the body to overproduce high levels of cortisol for a sustained period of time, which often results in characteristic physical signs and symptoms that are distressing to patients. The disease is most common among adults between the ages of 30–50, and it affects women three times more often than men. Women with Cushing's syndrome may experience a variety of health issues including menstrual problems, difficulty becoming pregnant, excess male hormones (androgens), primarily testosterone, which can cause hirsutism (growth of coarse body hair in a male pattern), oily skin, and acne. 3
Additionally, the multisystem complications of the disease are potentially life threatening. These include metabolic changes such as high blood sugar or diabetes, high blood pressure, high cholesterol, fragility of various tissues including blood vessels, skin, muscle, and bone, and psychological disturbances such as depression, anxiety, and insomnia. 3 Untreated, the five-year survival rate is only approximately 50%. 4
About Recorlev
Recorlev ® (levoketoconazole) is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. 1 Endogenous Cushing’s syndrome is a rare but serious and potentially fatal endocrine disease caused by chronic elevated cortisol exposure. 2 Recorlev is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor. 1 Recorlev has demonstrated in two successful Phase 3 studies to significantly reduce mean urinary free cortisol. 1
The Phase 3 program for Recorlev included LOGICS and SONICS, two multinational studies designed to evaluate the safety and efficacy of Recorlev when used to treat endogenous Cushing’s syndrome. LOGICS, a double-blind, placebo-controlled randomized-withdrawal study met its key endpoint of normalizing and maintaining therapeutic response compared with placebo (detailed results here ). 1 The supportive SONICS study met its primary and secondary endpoints, significantly reducing and normalizing mean urinary free cortisol concentrations without a dose increase. 1,2 The ongoing open-label OPTICS study will gather further useful information related to the long-term use of Recorlev.
Recorlev received orphan drug designation from the FDA and the European Medicines Agency for the treatment of endogenous Cushing's syndrome.