Capital Rx
Highlights
- Three key new drug approvals, including Cobenfy™ for the treatment of schizophrenia in adults
- Two notable expanded indications, including Lumryz™ - expanded to treat cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy
- Two biosimilar approvals, including Otulfi™ for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis
- 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 October 2024 Monthly Drug Update!
Key New Drug Approvals
Cobenfy™ (xanomeline and trospium chloride) capsule
Approval Date: 09/26/2024
Indication: Treatment of schizophrenia in adults
Cost*: $1,850 per month
Key Consideration:
• Novel mechanism of action (muscarinic agonist) for treatment of schizophrenia in adults
• Taken orally twice daily; starting dosage increased based on patient tolerability and response
• Does not have antipsychotic class warnings and precautions; no black box warnings
Itovebi™ (inavolisib) tablet
Approval Date: 10/10/2024
Indication: Treatment of endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, in combination with palbociclib and fulvestrant
Cost*: ~$23,000 per month
Key Consideration:
• Received priority review
• Granted breakthrough therapy designation
• Once daily oral tablet, taken with or without food, at approximately the same time each day
Press Release: https://www.gene.com/media/press-releases/15039/2024-10-10/fda-approves-genentechs-itovebi-a-target
Hympavzi™ (marstacimab-hncq) subcutaneous injection
Approval Date: 10/11/2024
Indication: Prevention of bleeding episodes in adults and adolescents ages 12 years and older with hemophilia A or B without inhibitors
Cost*: TBD
Key Consideration:
• Received orphan drug designation
• First and only anti-tissue pathway inhibitor (anti-TFPI) approved for treatment of hemophilia A or B
• First pre-filled, auto-injector hemophilia medication approved in the U.S.
• Injected subcutaneously once weekly
Press Release: https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-hympavzitm-marstacimab-hncq
Notable Expanded Indications
• Dupixent™ (dupilumab) – expanded indication for the add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype
• Lumryz™ (sodium oxybate) – expanded to treat cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy
Biosimilar Approvals
Otulfi™ (ustekinumab-aauz) subcutaneous injection
Approval Date: 09/27/2024
Indication: Treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis
Additional Information:
• Interchangeable biosimilar to Stelara® (ustekinumab)
• Intravenous (IV) formulation also FDA approved for the same indications
• Fourth Stelara biosimilar approved; anticipated launch in February 2025
Press Release: https://www.fresenius-kabi.com/news/fresenius-kabi-and-formycon-receive-us-fda-approval-for-biosimilar-otulfi
Imuldosa™ (ustekinumab-srif) subcutaneous injection
Approval Date: 10/10/2024
Indication: Treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis
Additional Information:
• Biosimilar to Stelara® (ustekinumab)
• Intravenous (IV) formulation also FDA approved for the same indications
• Fifth Stelara biosimilar approved; anticipated launch in May 2025
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