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

Key New Drug Approvals

Zegfrovy™ (sunvozertinib) tablet

Approval Date: 7/2/2025

Indication: Treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations in adults

Cost*: TBD

Key Consideration:
• First and only oral treatment approved for NSCLC with EGFR exon 20 insertion mutations
• Received priority review and Breakthrough Therapy Designation by the FDA
• Oral tablet taken once daily with food

‍Press Release: https://www.dizalpharma.com/news/detail?id=95&search=&currentPage=1

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Ekterly® (sebetralstat) tablet

‍Approval Date: 7/3/2025

Indication: Treatment of acute attacks of hereditary angioedema (HAE) in patients at least 12 years of age

Cost*: ~$8,360 per tablet

Key Consideration:
• First and only oral on-demand treatment for HAE approved by the FDA
• Received Orphan Drug Designation by the FDA
• Recommended dose is 2 tablets at onset of HAE attack; a second dose may be repeated in 3 hours if needed for a maximum of 4 tablets per 24 hours

Press Release: https://ir.kalvista.com/news-releases/news-release-details/kalvista-pharmaceuticals-announces-fda-approval-ekterlyr

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Notable Expanded Indications

• Kerendia® (finerenone) – expanded to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%

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Biosimilar Approvals

Kirsty™ (insulin aspart-xjhz) subcutaneous injection

‍Approval Date: 7/15/2025

Indication: Improve glycemic control in adults and pediatric patients with diabetes mellitus

Additional Information:
• First and only FDA approved biosimilar to NovoLog® (insulin aspart)
• Will be available as single-use prefilled-pens and multi-use vials

Press Release: https://www.bioconbiologics.com/biocon-biologics-expands-diabetes-portfolio-with-fda-approval-of-kirsty-the-first-and-only-interchangeable-rapid-acting-insulin-aspart-in-the-united-states/

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Generic Launches

• Eprontia® (topiramate) solution
• Xarelto® (rivaroxaban) suspension
• Dificid® (fidaxomicin) 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