Drug Pipeline & Clinical Update - March 2025
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Highlights
- Two key new drug approvals, including Ctexli™ (chenodiol) tablets for the treatment of cerebrotendinous xanthomatosis (CTX) in adults
- Seven notable expanded indications including Furoscix® – expanded to treat edema in patients with chronic kidney disease (CKD)
- Three biosimilar approvals, including Stoboclo® for the treatment of postmenopausal women with osteoporosis at high risk for fracture; to increase bone mass in men with osteoporosis at high risk for fracture; of glucocorticoid-induced osteoporosis in men and women at high risk for fracture; to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancerimproving glycemic control in adults and pediatric patients with diabetes mellitus
- Capital Rx's Updated Drug Recall Report: CLICK HERE to review
Capital Rx's Clinical Team closely monitors the drug landscape to provide our clients with timely information on newly FDA-approved medications, as well as products in the pipeline. Read on to review our March 2025 Monthly Drug Update!
Key New Drug Approvals
Ctexli™ (chenodiol) tablets
Approval Date: 2/21/2025
Indication: Treatment of cerebrotendinous xanthomatosis (CTX) in adults
Cost*: TBD
Key Consideration:
• First FDA approved drug to treat CTX, a rare genetic lipid storage disease
• Available as 250 mg oral tablets; recommended daily dose is 250 mg three times a day
• FDA granted Priority Review and Orphan Drug designations
Arbli™ (losartan) oral suspension
Approval Date: 3/13/2025
Indication: Treatment of hypertension in patients 6 years of age and older; reduction of risk of stroke in patients with hypertension and left ventricular hypertrophy; treatment of diabetic neuropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension
Cost*: TBD
Key Consideration:
• First and only FDA approved ready-to-use oral liquid formulation of losartan
• Once daily dosing for pediatric and adult patients
• Weight based dosing recommended for pediatric patients
Notable Expanded Indications
• Odefsey® (emtricitabine, rilpivirine, tenofovir alafenamide) – expanded to treat HIV-1 infection in adult and pediatric patients weighing at least 25 kg
• Neffy® (epinephrine) – expanded as emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients at least 4 years of age and weighing at least 15 kg
• Furoscix® (furosemide) – expanded to treat edema in patients with chronic kidney disease (CKD)
• Soliris® (eculizumab) – expanded to treat generalized myasthenia gravis (gMG) in patients at least 6 years of age
• Odactra™ (dermatophagoides farinae, dermatophagoides pteronyssinus) – expanded to treat house dust mite (HDM)-induced allergic rhinitis in patients 5-65 years of age
• Baqsimi™ (glucagon) – expanded to treat severe hypoglycemia in patients at least 1 year of age
• Tremfya® (guselkumab) – expanded to treat moderate to severe Crohn’s disease in adults
Biosimilar Approvals
Stoboclo® (denosumab-bmwo) subcutaneous injection
Approval Date: 2/28/2025
Indication: Treatment of postmenopausal women with osteoporosis at high risk for fracture; to increase bone mass in men with osteoporosis at high risk for fracture; of glucocorticoid-induced osteoporosis in men and women at high risk for fracture; to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
Additional Information:
• Biosimilar to Prolia® (denosumab)
• Healthcare administered
• Third Prolia® approved by the FDA
Press Release: https://www.celltrion.com/en-us/company/media-center/press-release/3768
Osenvelt® (denosumab-bmwo) subcutaneous injection
Approval Date: 2/28/2025
Indication: Prevention of skeletal-related events in patients with multiple myeloma; prevention of skeletal-related events in patients with bone metastases from solid tumors; treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy
Additional Information:
• Biosimilar to Xgeva® (denosumab)
• Healthcare administered
• Third Xgeva® approved by the FDA
Press Release: https://www.celltrion.com/en-us/company/media-center/press-release/3768
Omlyclo® (omalizumab-igec) subcutaneous injection
Approval Date: 3/7/2025
Indication: Treatment of moderate to severe persistent asthma in patients at least 6 years of age; treatment of chronic rhinosinusitis with nasal polyps in adults (as add-on maintenance treatment); treatment of IgE-mediated food allergy in patients at least 1 year of age; treatment of chronic spontaneous urticaria (CSU) in patients at least 12 years of age
Additional Information:
• First and only biosimilar to Xolair® (omalizumab)
• Received interchangeable designation
• Black box warning for anaphylaxis
Press Release: https://www.celltrion.com/en-us/company/media-center/press-release/3778
Generic Launches
• Namzaric® (memantine-donepezil 21-10 mg) extended-release capsule
• Xarelto® (rivaroxaban 2.5 mg) tablet
Contact Us if you'd like to learn more about Capital Rx's full-service pharmacy benefit management (PBM) solutions and clinical programs.
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* Cost: actual patient out-of-pocket costs may be lower, as the list price does not reflect insurance coverage, co-pay support for eligible patients, or financial assistance from patient support
