Drug Pipeline & Clinical Update - August 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 August 2025 Monthly Drug Update!

Key New Drug Approvals

Anzupgo® (delgocitinib) topical cream

Approval Date: 7/23/2025

Indication: Treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are not advisable or have had an inadequate response to

Cost*: $804 per 30-gram tube

Key Consideration:
• The first treatment specifically developed for management of chronic hand eczema
• Applied twice daily to hands and wrist; maximum use is 30 grams per 2 weeks or 60 grams per month

‍Press Release: https://www.businesswire.com/news/home/20250723115252/en/ANZUPGO-delgocitinib-Cream-Is-Now-the-First-and-Only-FDA-Approved-Treatment-for-Moderate-to-Severe-Chronic-Hand-Eczema-CHE-in-Adults

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Sephience™ (sepiapterin) oral powder

Approval Date: 7/28/2025

Indication: Treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU)

Cost*: ~$492,000 annually

Key Consideration:
• To be used in conjunction with a phenylalanine (Phe)- restricted diet
• Oral powder is mixed with water or apple juice and administered once daily with food
• Weight based dosing
• Received Orphan Drug Designation by the FDA

‍Press Release: https://ir.ptcbio.com/news-releases/news-release-details/ptc-therapeutics-announces-fda-approval-sephiencetm-sepiapterin?mobile=1

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Vizz™ (aceclidine) ophthalmic solution

Approval Date: 7/31/2025

Indication: Treatment of presbyopia in adults

Cost*: TBD

Key Consideration:
• The first and only aceclidine-based eye drop approved to improve near vision in adults with presbyopia
• The first once daily ophthalmic solution to treat presbyopia with proven efficacy for up to 10 hours

‍Press Release: https://ir.lenz-tx.com/news-events/press-releases/detail/39/lenz-therapeutics-announces-us-fda-approval-of-vizz-for-the-treatment-of-presbyopia

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Hernexeos® (zongertinib) tablet

Approval Date: 8/8/2025

Indication: Treatment of unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) in adult patients whose tumors have HER2 tyrosine kinase domain activating mutations and have received prior systemic therapy

Cost*: TBD

Key Consideration:
• Once daily oral tablet, taken with or without food until disease progression or unacceptable toxicity
• First oral targeted therapy for patients with HER2-mutant advanced NSCLC after prior systemic therapy
• Received Priority Review, accelerated approval, and Breakthrough Therapy Designation by the FDA

‍Press Release: https://www.boehringer-ingelheim.com/human-health/cancer/lung-cancer/fda-approval-hernexeos-first-oral-treatment-her2-mutant-advanced-nsclc

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Brinsupri™ (brensocatib) tablet

Approval Date: 8/12/2025

Indication: Treatment of non-cystic fibrosis bronchiectasis in patients 12 years of age and older

Cost*: $88,000 annually

Key Consideration:
• Once daily oral tablet, taken with or without food
• The first and only treatment for non-cystic fibrosis bronchiectasis
• Received Priority Review by the FDA

‍Press Release: https://investor.insmed.com/2025-08-12-FDA-Approves-BRINSUPRI-TM-brensocatib-as-the-First-and-Only-Treatment-for-Non-Cystic-Fibrosis-Bronchiectasis,-a-Serious,-Chronic-Lung-Disease

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Notable Expanded Indications

• Doptelet®; Doptelet® Sprinkle (avatrombopag) – expanded to treat thrombocytopenia in patients at least 1 year of age with persistent or chronic immune thrombocytopenia who had an inadequate response to previous treatment
• Sirturo® (bedaquiline) – expanded to treat patients at least 2 years of age, weighing at least 8 kg with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid
• Empaveli® (pegcetacoplan) – expanded to reduce proteinuria in patients 12 years of age and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN)
• Biktarvy® (bictegravir, emtricitabine, and tenofovir alafenamide) – expanded to treat HIV-1 infection in patients weighing at least 14 kg, with an antiretroviral treatment history and not virologically suppressed, with no known or suspected resistance to any component in Biktarvy®
• Leqvio® (inclisirin) – expanded to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH) [adjunct to statin therapy removed]
• Phyrago® (dasatinib) – expanded to treat patients 1 year of age and older with Ph+ CML in chronic phase; expanded to treat patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy

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‍‍Generic Launches

• Vuity® (pilocarpine) ophthalmic solution

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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

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