Capital Rx
Highlights
- Three key new drug approvals, all "first" of their respective kinds
- Three notable expanded indications
- Six 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 February 2024 Monthly Drug Update!
Key New Drug Approvals
Eohilia™ (budesonide) oral suspension
Approval Date: 02/12/2024 - CLICK HERE for the press release
Indication: Eosinophilic esophagitis
Cost*: $37.50 per packet
Key Considerations:
- First and only oral corticosteroid treatment in the U.S. for individuals 11 years of age and older with eosinophilic esophagitis administered twice daily for 12 weeks
- Approved via the 505b2 FDA approval pathway using budesonide as the reference product
- Orphan drug designation
Aurlumyn™ (iloprost) intravenous injection
Approval Date: 02/14/2024 - CLICK HERE for the press release
Indication: Severe frostbite
Cost*: TBD
Key Considerations:
- First and only treatment for severe frostbite in adults to lower the risk of amputation of fingers or toes
- Approved via the 505b2 FDA approval pathway using iloprost as the reference drug
- Received priority review and orphan drug designation
Amtagvi™ (lifileucel) intravenous infusion
Approval Date: 02/16/2024 - CLICK HERE for the press release
Indication: Unresectable or metastatic melanoma
Cost*: $515,000 per one-time infusion
Key Considerations:
- First cellular therapy for adult patients with unresectable or metastatic melanoma previously treated with a programmed cell death protein-1 blocking antibody, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor
- Boxed warning for the risk of treatment-related mortality, prolonged severe cytopenia, severe infection, and cardiopulmonary and renal impairment
- Granted accelerated approval and orphan drug designation
Notable Expanded Indications
Onivyde® (irinotecan liposome injection) intravenous injection - expanded to be used with oxaliplatin, fluorouracil, and leucovorin, for first-line treatment of metastatic pancreatic adenocarcinoma.
Tagrisso® (osimertinib) tablet - expanded to be used with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected.
Xolair® (omalizumab) subcutaneous injection - expanded to be used for the reduction of accidental allergic food reactions, including anaphylaxis, in adults and children ages 1 year and older.
Generic Launches
Korlym® (mifepristone 300mg) tablet
Gralise® (gabapentin 300mg, 600mg) once-daily tablet
BromSite® (bromfenac 0.075%) ophthalmic solution
Pradaxa® (dabigatran 110mg) capsule
Emflaza® (deflazacort 6mg, 18mg, 30mg, 36mg) tablet
Alrex® (loteprednol 2%) ophthalmic suspension
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