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Capital Rx
Highlights
- Five key new drug approvals, including Journavx™ tablet for the treatment of moderate to severe acute pain in adults
- One notable expanded indication, for Ozempic™ injection – expanded indication to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease
- Two biosimilar approvals, including Merilog™ injection for improving glycemic control in adults and pediatric patients with diabetes mellitus
- 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 February 2025 Monthly Drug Update!
Key New Drug Approvals
Journavx™ (suzetrigine) tablet
Approval Date: 1/30/2025
Indication: Treatment of moderate to severe acute pain in adults
Cost*: $450 for 14-day course
Key Consideration:
• Non-opioid, highly selective sodium channel blocker, and the first new class of pain medicine to be FDA-approved in more than 20 years
• FDA granted Breakthrough Therapy, Fast Track, and Priority Review Designations
• Available as a 50 mg tablet; recommended first dose is 100 mg (2 tablets), followed by 50 mg (1 tablet) every 12 hours thereafter
• Use beyond 14 days has not been studied for this indication
Press Release: https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class
Symbravo™ (meloxicam and rizatriptan) tablet
Approval Date: 1/30/2025
Indication: Acute treatment of migraine with or without aura in adults
Cost*: TBD
Key Consideration:
• Combination product of meloxicam, a non-steroidal anti-inflammatory drug (NSAID), and rizatriptan, a serotonin 1B/1D receptor agonist (triptan)
• Available as a tablet containing 20 mg of meloxicam and 10 mg of rizatriptan; recommended and maximum daily dose is one tablet by mouth as needed
Press Release: https://www.multivu.com/axsome_therapeutics/9311751-en-axsome-therapeutics-symbravo-fda-approval-acute-treatment-migraine
Onapgo™ (apomorphine) injection
Approval Date: 2/4/2025
Indication: Treatment of motor fluctuations in adults with advanced Parkinson’s disease
Cost*: TBD
Key Consideration:
•First and only subcutaneous apomorphine infusion device for this indication
• Second subcutaneous pump recently approved for the treatment of Parkinson’s disease following the approval of Vyalev™ (foslevodopa-foscarbidopa) in October 2024
• Available as a 98 mg/20 mL single-dose cartridge; maximum recommended total daily dosage, including the continuous dosage and any extra dose(s), is 98 mg generally administered over the waking day (e.g., 16 hours)
• Manufacturer expects this product to launch in Q2 2025
Press Release: https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-onapgotm-apomorphine
Gomekli™ (mirdametinib) capsule and tablet for oral suspension
Approval Date: 2/11/2025
Indication: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas not amenable to complete resection
Cost*: TBD
Key Consideration:
•FDA granted Orphan Drug, Fast Track, and Priority Review Designations
• NF1 is a genetic disorder that affects approximately 100,000 children in the United States; patients can develop plexiform neurofibromas, which are tumors that can cause severe disfigurement, pain, and functional impairment
• Available as 1 mg and 2 mg oral capsule and 1 mg tablet for oral suspension; recommended dosage is 2 mg/m2 orally twice daily for the first 21 days of each 28-day cycle
Press Release: https://ir.springworkstx.com/news-releases/news-release-details/springworks-therapeutics-announces-fda-approval-gomeklitm
Romvimza™ (vimseltinib) capsule
Approval Date: 2/14/2025
Indication: Treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity
Cost*: TBD
Key Consideration:
• Second FDA-approved systemic therapy for TGCT; first FDA-approved product for this indication was Turalio™ (pexidartinib)
• Available as a 14 mg, 20 mg, 30 mg capsule; recommended dosage is 30 mg orally twice weekly, with a minimum of 72 hours between doses
• Additional treatments for TGCT are currently in Phase 3 Trials, including SynOx Therapeutics’ emactuzumab and Abbisko Therapeutics’ pimicotinib
Press Release: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor
Notable Expanded Indications
• Ozempic™ (semaglutide) injection – expanded indication to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease
Biosimilar Approvals
Avtozma™ (tocilizumab-anoh) injection
Approval Date: 1/24/2025
Indication: Treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19
Additional Information:
• Biosimilar to Actemra™ (tocilizumab)
• Both subcutaneous (SC) and intravenous (IV) formulations were FDA-approved
• Third Actemra™ biosimilar approved; launch expected in 2025
Press Release: https://www.celltrion.com/en-us/company/media-center/press-release/3668
Merilog™ (insulin aspart-szjj) injection
Approval Date: 2/14/2025
Indication: Improve glycemic control in adults and pediatric patients with diabetes mellitus
Additional Information:
• Biosimilar to Novolog™ (insulin aspart)
• Third insulin biosimilar, but first rapid-acting insulin biosimilar to be FDA-approved
• Approved in both 3 mL single-dose prefilled pens (Merilog™ SoloStar) and as a 10 mL multiple-dose vial
Press Release: https://www.fda.gov/news-events/press-announcements/fda-approves-first-rapid-acting-insulin-biosimilar-product-treatment-diabetes
Generic Launches
• Mesnex™ (mesna 400 mg) tablet
FDA Safety Alert
The FDA added a new Boxed Warning to the Prescribing Information for Copaxone™ (glatiramer acetate) and Glatopa™ (glatiramer acetate) due to an increased risk of anaphylaxis.
The new safety language in the Warnings and Precautions section for both products states “life-threatening and fatal anaphylaxis has been reported with Copaxone/Glatopa” and “anaphylaxis can occur at any time following initiation of Copaxone/Glatopa therapy, from as early as after the first dose, up to years after initiation of treatment.”
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