Drug Pipeline & Clinical Update - April 2025

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 April 2025 Monthly Drug Update!

Key New Drug Approvals

Blujepa (gepotidacin) tablets

Approval Date: 3/25/2025

Indication: Treatment of uncomplicated urinary tract infections (uUTI) caused by Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis in females at least 12 years of age and weighing at least 40 kilograms cerebrotendinous xanthomatosis (CTX) in adults

Cost*: TBD

Key Consideration:
• First new antibiotic class (triazaacenaphthylene bacterial type II topoisomerase inhibitor) approved by the FDA for uUTI in nearly 30 years
• Available as a 750 mg oral tablet; recommended dosage is 2 tablets (1,500 mg) twice daily after a meal for 5 days
• FDA granted Priority Review

Press Release: https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/
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Vykat^TM XR (diazoxide choline) extended-release tablets

‍Approval Date: 03/26/2025

Indication: Treatment of hyperphagia in patients at least 4 years of age with Prader-Willi syndrome (PWS)

Cost*: $466,000 annually

Key Consideration:
• First and only FDA approved treatment for hyperphagia in PWS
• Dosing is weight based and titrated over 6 weeks to target maintenance dose (up to 525 mg per day)
• Do not substitute with diazoxide oral suspension

Press Release: https://investors.soleno.life/news-releases/news-release-details/soleno-therapeutics-announces-us-fda-approval-vykattm-xr-treat‍
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Qfitlia^TM (fitusiran) subcutaneous injection

‍Approval Date: 03/28/2025

Indication: Prevention or reduction of frequency of bleeding episodes in patients at least 12 years old with hemophilia A or B with or without factor VIII or IX inhibitors

Cost*: $642,000 annually

Key Consideration:
• First-in-class antithrombin-lowering agent approved for hemophilia
• Self-administered injection that offers consistent protection with as few as six injections per year
• Available as a single-dose vial or single-dose prefilled pen
• FDA granted Orphan Drug Designation

Press Release: https://www.sanofi.com/en/media-room/press-releases/2025/2025-03-28-20-07-38-3051637

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Vanrafia^TM (atrasentan) tablets

‍Approval Date: 04/02/2025

Indication: Reduce proteinuria in adults with primary immunoglobulin Anephropathy (IgAN) at risk of rapid disease progression

‍Cost*: $162,500 annually

Key Consideration:
• First and only selective endothelin A receptor antagonist approved by the FDA for IgAN
• Once daily oral tablet taken with or without food
• Black Box Warning for causing major birth defects if used during pregnancy
• FDA granted Orphan Drug Designation

Press Release: https://www.novartis.com/us-en/news/media-releases/novartis-receives-fda-accelerated-approval-vanrafia-atrasentan-first-and-only-selective-endothelin-receptor-antagonist-proteinuria-reduction-primary-iga-nephropathy-igan

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Notable Expanded Indications

• Amvuttra® (vutrisiran) – expanded to treat the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits

• Tremfya® (guselkumab) – expanded to treat moderate to severe Crohn’s disease

• Prezcobix® (darunavir, cobicistat) – expanded to treat HIV-1 infection in patients weighing at least 25 kg

• Cabometyx® (cabozantinib) – expanded to treat previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and extra-pancreatic neuroendocrine tumors (epNET) in patients at least 12 years of age

• Sivextro® (tedizolid) – expanded to treat acute bacterial skin and skin structure infections (ABSSSI) in patients at least 26 weeks gestational age and weighing at least 1 kilogram

• Dupixent® (dupilumab) – expanded to treat chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment in patients at least 12 years of age

• Yuflyma® (adalimumab-aaty) – granted interchangeable designation to Humira® (adalimumab)
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Biosimilar Approvals

Bomyntra® (denosumab-bnht) subcutaneous injection

Approval Date: 3/25/2025

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® biosimilar approved by the FDA

Press Release: https://www.fresenius-kabi.com/news/fda-approval-for-denosumab-biosimilars
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Conexxence® (denosumab-bnht) subcutaneous injection

Approval Date: 3/25/2025

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® biosimilar approved by the FDA

Press Release: https://www.fresenius-kabi.com/news/fda-approval-for-denosumab-biosimilars
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‍Generic Launches

• Brilinta® (ticagrelor 90 mg) tablet

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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