Capital Rx
Highlights
- Two key new drug approvals, including PiaSky® for PNH
- One notable expanded indication - Zoryve® for atopic dermatitis
- Three biosimilar approvals (including alternatives to Eylea® and Neupogen®) and four generic launches
- 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 July 2024 Monthly Drug Update!
Key New Drug Approvals
PiaSky® (crovalimab-akkz) intravenous/subcutaneous injection
Approval Date: 06/20/2024
Indication: Treatment of paroxysmal nocturnal hemoglobinura (PNH) in patients at least 13 years of age and body weight of at least 40 kg
Cost*: TBD
Key Consideration:
• Intravenous (IV) loading dose, followed by subcutaneous (SC) maintenance dose
• Orphan drug designation
• Black box warning for serious and life-threatening infections caused by Neisseria meningitidis
For more information: https://www.empr.com/home/news/piasky-approved-for-paroxysmal-nocturnal-hemoglobinuria/
Ohtuvayre™ (ensifentrine) inhalation suspension
Approval Date: 06/26/2024
Indication: Treatment of chronic obstructive pulmonary disease (COPD) in adults
Cost*: $36,000 per year
Key Consideration:
• First inhaled maintenance therapy that combines bronchodilator and non-steroidal anti-inflammatory (NSAID) activities in one drug molecule
Press Release: https://www.veronapharma.com/news/verona-pharma-announces-us-fda-approval-of-ohtuvayre-ensifentrine/
Notable Expanded Indications
Zoryve® (roflumilast 0.15%, 0.3%) – expanded to treat mild to moderate atopic dermatitis in patients 6 years of age and older
Biosimilar Approvals
Nypozi™ (filgrastim-txid) intravenous/subcutaneous injection
Approval Date: 06/28/2024
Indication: Decrease incidence of febrile neutropenia; reduce time to neutrophil recovery and duration of fever following induction or consolidation of chemotherapy in patients with AML; reduce duration of neutropenia and neutropenia-related clinical sequelae in patients with nonmyeloid malignancies; mobilize autologous hematopoietic progenitor cells; reduce the incidence and duration of severe neutropenia in symptomatic patients with congenital, cyclic, or idiopathic neutropenia; increase survival in patients acutely exposed to myelosuppressive doses of radiation
Additional Information:
• Fourth biosimilar to Neupogen®
Press Release: https://www.tanvex.com/PDF/News/Tanvex%20received%20BLA%20approval%20from%20FDA.pdf
Ahzantive™ (aflibercept-mrbb) intravitreal injection
Approval Date: 06/28/2024
Indication: Treatment of Neovascular (wet) Age-Related Macular Degeneration (AMD), treatment of Macular Edema following Retinal Vein Occlusion (RVO), treatment of Diabetic Macular Edema (DME), treatment of Diabetic Retinopathy (DR)
Additional Information:
• Biosimilar to Eylea®
Press Release: https://www.formycon.com/en/blog/press-release/formycon-receives-fda-approval-for-fyb203-ahzantive/
Pyzchiva® (ustekinumab-ttwe) intravenous/subcutaneous injection
Approval Date: 06/28/2024
Indication: Treatment of Crohn’s disease in adults; treatment of ulcerative colitis in adults; treatment of psoriasis in patients 6 years of age or older; treatment of psoriatic arthritis in patients 6 years of age or older
Additional Information:
• Interchangeable biosimilar to Stelara®
Press Release: https://www.sandoz.com/fda-approves-biosimilar-pyzchivar-ustekinumab-ttwe-be-commercialized-sandoz-us/
Generic Launches
Victoza® (liraglutide 18 mg/3mL) subcutaneous injection
Halog® (halcinonide 0.1%) topical solution
Endari® (l-glutamine 5 g/packet) oral powder
Corlanor® (ivabradine 5 mg, 7.5 mg) tablet
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