Capital Rx
Highlights
- One new approval - Zelsuvmi™ topical gel
- Three new notable expanded indications
- One biosimilar approval: Udenyca Onbody™
- One notable generic launch - Prolensa®
- 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 January 2024 Monthly Drug Update!
Key New Drug Approvals
Zelsuvmi™ (berdazimer) topical gel
Approval Date: 01/05/2024 - CLICK HERE for the press release
Indication: Molluscum contagiosum
Cost*: TBD
Key Considerations:
- First novel prescription drug indicated for the treatment of molluscum contagiosum in adults and pediatric patients one year of age and older
- First and only topical prescription medication that can be applied by patients or caregivers at home, outside of a healthcare setting to treat this highly contagious viral skin infection
- Expected U.S. availability in second half of 2024
Notable Expanded Indications
Keytruda® (pembrolizumab) intravenous solution- expanded to be used in combination with chemotherapy with or without bevacizumab for the treatment of adults with persistent, recurrent, or metastatic cervical cancer
HyQvia® (immune globulin infusion/recombinant human hyaluronidase) subcutaneous injection- expanded to be used for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults
Balversa® (erdafitinib) tablet- expanded to be used for the treatment of adult patients with locally or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy
Biosimilar Approvals
Udenyca Onbody™ (pegfilgrastim-cbqv) subcutaneous injection
Approval Date: 12/26/2023 - CLICK HERE for the press release
Indication: Administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia
Additional Information:
- Biosimilar referencing Neulasta Onpro®
- First and only pegfilgrastim biosimilar on-body injector delivery system
- Launch timeline is expected in Q1 of 2024 by the manufacturer, Coherus
Generic Launches
Prolensa® (bromfenac 0.07%) ophthalmic solution
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