Capital Rx
Highlights
- Three key new drug approvals, including Ebglyss™ subcutaneous injection for treatment of moderate-to-severe atopic dermatitis
- One notable expanded indications -Kisqali® expanded to treat hormone receptor (HR)-positive, HER2-negative stage II and III early breast cancer
- One biosimilar approval - Pavblu™ for Treatment of neovascular (wet) age-related macular degeneration (AMD), treatment of macular edema following retinal vein occlusion (RVO), treatment of diabetic macular edema, and treatment of diabetic retinopathy
- 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 September 2024 Monthly Drug Update!
Key New Drug Approvals
Lazcluze™ (lazertinib) tablet
Approval Date: 08/19/2024
Indication: Treatment, in combination with amivantamab, of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations
Cost*: TBD
Key Consideration:
• Approved as first-line chemotherapy-free regimen when taken with amivantamab
• Received priority review
• Once daily tablet taken with or without food
• Administer prior to amivantamab when given on the same day
Ebglyss™ (lebrikizumab-lbkz) subcutaneous injection
Approval Date: 09/13/2024
Indication: Treatment of moderate-to-severe atopic dermatitis in patients 12 years of age and older who weigh at least 40 kg whose disease is not well controlled by topical therapy
Cost*: TBD
Key Consideration:
• Targeted IL-13 inhibitor
• Can be used with or without topical corticosteroids
• Administered every 2 weeks until adequate clinical response is achieved (week 16 or later), followed by maintenance dose of every 4 weeks
Press Release: https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and
Miplyffa™ (arimoclomol) capsule
Approval Date: 09/20/2024
Indication: Treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in patients 2 years of age and older, used in combination with miglustat
Cost*: $40,000 - $106,000 per month
Key Consideration:
• Orphan drug designation
• Received priority review
• First FDA approved treatment for Niemann-Pick disease type C (NPC)
Press Release: https://investors.kempharm.com/news-releases/news-release-details/zevra-therapeutics-miplyffatm-arimoclomol-receives-us-fda
Notable Expanded Indications
Kisqali® (ribociclib) and Kisqali Femara Co-Pack (ribociclib and letrozole) – expanded to treat hormone receptor (HR)-positive, HER2-negative stage II and III early breast cancer at high risk of occurrence, in combination with an aromatase inhibitor
Biosimilar Approvals
Pavblu™ (aflibercept-ayyh) IVT
Approval Date: 08/23/2024
Indication: Treatment of neovascular (wet) age-related macular degeneration (AMD); treatment of macular edema following retinal vein occlusion (RVO); treatment of diabetic macular edema; treatment of diabetic retinopathy
Additional Information:
• Fifth biosimilar of Eylea®
Generic Launches
Lucemyra® (lofexidine 0.18 mg) tablet
Oxtellar XR® (oxcarbazepine ER 24hr, 150 mg, 300 mg, 600mg) tablet
Sprycel® (dasatinib) tablet
Tazorac® (tazarotene 0.05%) cream
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