Capital Rx
Highlights
- Five key new drug approvals, including IbtroziTM (taletrectinib) for treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults
- Four notable expanded indications including Mavyret® (glecaprevir/pibrentasvir) – expanded to treat acute or chronic hepatitis C virus (HCV) infection in patients at least 3 years of age, with or without compensated cirrhosis (Child-Pugh A)
- Two generic launches including Tasigna® (nilotinib)
- 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 June 2025 Monthly Drug Update!
Key New Drug Approvals
Tryptyr® (acoltremon) ophthalmic solution
Approval Date: 5/28/2025
Indication: Treatment of the signs and symptoms of dry eye disease (DED)
Cost*: TBD
Key Consideration:
• First-in-class TRPM8 receptor agonist that rapidly stimulates natural tear production
• Recommended dose is 1 drop in each eye twice daily (approximately 12 hours apart)
• Available in single dose vials
Khindivi™ (hydrocortisone) solution
Approval Date: 5/28/2025
Indication: Corticosteroid replacement therapy in patients 5 years of age and older with adrenocortical insufficiency
Cost*: TBD
Key Consideration:
• First and only FDA approved hydrocortisone oral solution
• Ready to use oral liquid solution that does not require refrigeration, mixing, or shaking
• Dosing is based on Body Surface Area (BSA)
Press Release: https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-us-fda-approval-khindivitm
Widaplik™ (telmisartan; amlodipine; indapamide) tablet
Approval Date: 6/5/2025
Indication: Treatment of hypertension
Cost*: TBD
Key Consideration:
• First and only triple combination of an angiotensin II receptor blocker (telmisartan), calcium channel blocker (amlodipine), and thiazide-like diuretic (indapamide)
• First and only triple combination approved for the initial treatment of hypertension
• Black Box Warning for use in pregnancy
Ibtrozi™ (taletrectinib) capsule
Approval Date: 06/11/2025
Indication: Treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults
Cost*: TBD
Key Consideration:
• Received Priority Review and Orphan Drug Designation by the FDA
• Recommended dose is 600 mg orally once daily on an empty stomach (no food intake at least 2 hours before or 2 hours after taking)
Andembry® (garadacimab-gxii) subcutaneous injection
Approval Date: 06/16/2025
Indication: Prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older
Cost*: TBD
Key Consideration:
• Once monthly self-administered subcutaneous injection
• First and only FDA approved treatment targeting factor XIIa for prophylactic use for prevention of HAE attacks
Notable Expanded Indications
• Nubeqa® (darolutamide) – expanded to treat metastatic castration-sensitive prostate cancer (mCSPC)
• Mavyret® (glecaprevir/pibrentasvir) – expanded to treat acute or chronic hepatitis C virus (HCV) infection in patients at least 3 years of age, with or without compensated cirrhosis (Child-Pugh A)
• Talzenna® (talazoparib) – expanded to treat metastatic castration-resistant prostate cancer mCRPC) in combination with Xtandi® (enzalutamide)
• Dupixent® (dupilumab) – expanded to treat bullous pemphigoid in adults
Generic Launches
• Tasigna® (nilotinib) capsule
• Fycompa® (perampanel) 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