Capital Rx
Highlights
- Nine key new drug approvals, including Femlyv contraceptive tablet
- Two notable expanded indications - including Fabhalta® for the reduction of proteinuria in adults with primary IgAN
- One biosimilar approval - Enzeevu™ for neovascular AMD
- 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 August 2024 Monthly Drug Update!
Key New Drug Approvals
Femlyv (norethindrone; ethinyl estradiol) ODT tablet
Approval Date: 07/22/2024
Indication: Prevention of pregnancy
Cost*: TBD
Key Consideration:
• First dissolving contraceptive tablet approved by the FDA
• Tablet should be dissolved on tongue then followed by drinking 8 ounces of water
For more information: https://www.fda.gov/news-events/press-announcements/fda-roundup-july-23-2024
Leqselvi™ (deuruxolitinib) tablet
Approval Date: 07/25/2024
Indication: Treatment of severe alopecia areata in adults
Cost*: TBD
Key Consideration:
• Twice daily oral tablet, taken with or without food
• Black box warning for serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis
Press release: https://sunpharma.com/wp-content/uploads/2024/07/Sunpharma-LEQSELVI-Approval-Scenario-Press-Release.pdf
Zunveyl® (benzgalantamine) tablet
Approval Date: 07/26/2024
Indication: Treatment of mild to moderate dementia of Alzheimer’s disease in adults
Cost*: TBD
Key Consideration:
• Twice daily delayed release tablet
• Prodrug of galantamine, reducing GI and insomnia side effects
Press release: https://www.alphacognition.com/investors/news/alpha-cognitions-oral-therapy-zunveyl-receives-fda-approval-to-treat-alzheimers-disease-
Voranigo® (vorasidenib) tablet
Approval Date: 08/06/2024
Indication: Treatment of grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection in patients 12 years and older
Cost*: ~$40,000 per month
Key Consideration:
• First targeted therapy for grade 2 IDH mutant glioma
• Received priority review
• Orphan drug designation
For more information: https://servier.us/blog/serviers-voranigo-vorasidenib-tablets-receives-fda-approval-as-first-targeted-therapy-for-grade-2-idh-mutant-glioma/?utm_campaign=vora_ann_webbanner_popup
Crexont™ (carbidopa; levodopa) ER capsule
Approval Date: 08/07/2024
Indication: Treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide or manganese intoxication in adults
Cost*: TBD
Key Consideration:
• Capsules contain immediate-release carbidopa/levodopa granules, as well as extended-release levodopa pellets
• Dosage conversions from immediate-release carbidopa/levodopa to CrexontTM are required (not 1:1)
Yorvipath® (palopegteriparatide) subcutaneous injection
Approval Date: 08/09/2024
Indication: Treatment of hypoparathyroidism
Cost*: TBD
Key Consideration:
• First and only treatment for hypoparathyroidism in adults
• Received priority review
• Orphan drug designation
Press release: https://investors.ascendispharma.com/news-releases/news-release-details/fda-approves-yorvipathr-palopegteriparatide-first-and-only
Neffy® (epinephrine) nasal spray
Approval Date: 08/09/2024
Indication: Emergency treatment of type 1 allergic reactions, including anaphylaxis, in patients weighing at least 30 kg
Cost*: ~$350 per dose
Key Consideration:
• First needle free (nasal spray) treatment for anaphylaxis
• Recommended that all patients always have access to two Neffy® nasal sprays to ensure proper treatment in the event a second dose is needed during reaction
Press release: https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-neffyr-epinephrine
Nemluvio® (nemolizumab-ilto) subcutaneous injection
Approval Date: 08/12/2024
Indication: Treatment of prurigo nodularis in adults
Cost*: TBD
Key Consideration:
• First monoclonal antibody approved by the FDA to target interleukin (IL)-31 signaling
• Received priority review
• Breakthrough therapy designation
Press release: https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo
Livdelzi® (seladelpar) capsules
Approval Date: 08/14/2024
Indication: Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA
Cost*: ~$12,600 per month
Key Consideration:
• Received priority review
• Received accelerated approval
• Orphan drug designation
For more information: https://www.livdelzi.com/?gad_source=1&gclid=EAIaIQobChMI94HTioOCiAMVTzUIBR1YtSj1EAAYASAAEgKNovD_BwE&gclsrc=aw.ds
Notable Expanded Indications
Fabhalta® (iptacopan) – expanded for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN)
Furoscix® (furosemide) – expanded to treat fluid overload in chronic heart failure
Biosimilar Approvals
Enzeevu™ (aflibercept-abzv) intravitreal injection
Approval Date: 08/09/2024
Indication: Treatment of neovascular (wet) age-related macular degeneration (AMD)
Additional Information:
• Fourth biosimilar to Eylea®
• Not approved for all of the same indications as reference product, Eylea®
Press Release: https://www.sandoz.com/sandoz-receives-fda-approval-enzeevutm-aflibercept-abzv-further-strengthening-us-biosimilar/
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