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

Key New Drug Approvals

Atzumi™ (dihydroergotamine) nasal powder

Approval Date: 4/30/2025

Indication: Acute treatment of migraine with or without aura in adults

Cost*: TBD

Key Consideration:
• Cardiovascular evaluation is recommended prior to initiation
• Maximum recommended dose is no more than 4 doses in a 7-day period or 12 doses within a 30-day period

Press Release: https://ssl4.eir-parts.net/doc/2395/tdnet/2601366/00.pdf

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Avmapki™ Fakzynja™ Co-Pack (avutometinib; defactinib) capsules; tablets

‍Approval Date: 05/08/2025

Indication: Treatment of KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) in adults who have received prior systemic therapy

Cost*: TBD

Key Consideration:
• First and only FDA approved treatment for KRAS-mutated recurrent LGSOC
• FDA granted Orphan Drug Designation and Priority Review
• Avmapki™  is an oral capsule taken twice weekly (Day 1 and Day 4) for the first 3 weeks of each 4-week cycle; Fakzynja™ is an oral tablet taken twice daily for the first 3 weeks of each 4-week cycle

Press Release: https://investor.verastem.com/news-releases/news-release-details/fda-approves-avmapkitm-fakzynjatm-combination-therapy-first-ever

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Brekiya® (dihydroergotamine) subcutaneous injection

‍Approval Date: 05/14/2025

Indication: Acute treatment of migraine with or without aura in adults; Acute treatment of cluster headaches in adults

Cost*: TBD

Key Consideration:
• First and only dihydroergotamine (DHE) autoinjector that allows patients to self-administer
• Cardiovascular evaluation is recommended prior to initiation
• Maximum recommended dose is no more than 3 doses in a 24-hour period and no more than 6 doses in a 7-day period

Press Release: https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Receives-U-S--FDA-Approval-for-Brekiya-dihydroergotamine-mesylate-injection-for-the-Acute-Treatment-of-Migraine-and-Cluster-Headaches-in-Adults/default.aspx

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Notable Expanded Indications

• Rinvoq® (upadacitinib) – expanded to treat adults with giant cell arteritis

• Zoryve® (roflumilast) – expanded to treat plaque psoriasis in patients 12 years of age and older

• Welireg™ (belzutifan) – expanded to treat advanced, unresectable, or metastatic pheochromocytoma or paraganglioma in patients 12 years of age and older

• Nucala (mepolizumab) – expanded to treat chronic obstructive pulmonary disease (COPD) as add-on maintenance treatment in adults
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Generic Launches

• Brilinta® (ticagrelor) tablet
• Qsymia® (phentermine; topiramate) capsule
• Aptiom® (eslicarbazepine) tablet
• Jynarque® (tolvaptan) tablet
• Promacta (eltrombopag) tablet, packet

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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