Capital Rx
Highlights
- Six key new approvals
- Six new notable expanded indications
- One biosimilar approval: Avzivi™ for certain types of CRC
- Four notable 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 December 2023 Monthly Drug Update!
Key New Drug Approvals
Alvaiz™ (eltrombopag) tablet
Approval Date: 11/29/2023 - CLICK HERE for the press release
Indication: Moderate to severe active ulcerative colitis
Cost*: TBD
Key Considerations:
- Indicated for the treatment of thrombocytopenia in adult and pediatric patients six years of age and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
- Should be administered in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk of bleeding
- Patients with myelodysplastic syndrome should be advised not to use this medication
- Black box warning for risk of hepatic decompensation in patients with Chronic Hepatitis C and risk of Hepatotoxicity
Fabhalta® (iptacopan) capsule
Approval Date: 12/05/2023 - CLICK HERE for the press release
Indication: Paroxysmal nocturnal hemoglobinuria
Cost*: $550,000 annually (WAC)
Key Considerations:
- First oral monotherapy approved for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria
- Black Box Warning for an increased risk of serious infections caused by encapsulated bacteria
- Available only through a Risk Evaluation and Mitigation Strategy (REMS) program that requires vaccinations for encapsulated bacteria
Iwilfin™ (eflornithine) tablet
Approval Date: 12/13/2023 - CLICK HERE for the press release
Indication: Pediatric Neuroblastoma
Cost*: $262,800 annually (WAC)
Key Considerations:
- Indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have demonstrated at least a partial response to prior muti-agent, multi-modality therapy including anti-GD2 immunotherapy
- First FDA-approved drug to reduce the risk of relapse in pediatric patients with high-risk neuroblastoma
Zoryve® (roflumilast) 0.3% foam
Approval Date: 12/15/2023 - CLICK HERE for the press release
Indication: Seborrheic dermatitis of the scalp
Cost*: TBD
Key Considerations:
- Indicated for the treatment of seborrheic dermatitis in individuals 9 years of age and older
- First drug approved for seborrheic dermatitis with a new mechanism of action in over two decades
- Expected to be commercially available by end of January 2024
Filsuvez® (birch triterpenes) topical gel
Approval Date: 12/19/2023 - CLICK HERE for the press release
Indication: Epidermolysis bullosa
Cost*: TBD
Key Considerations:
- Topical gel indicated for the treatment of partial thickness wounds in patients six months of age and older with Junctional and Dystrophic Epidermolysis Bullosa
- First approved treatment for wounds associated with Junctional Epidermolysis Bullosa, a rare, moderate to severe form of Epidermolysis Bullosa with blisters beginning in infancy
Wainua™ (eplontersen) subcutaneous injection
Approval Date: 12/21/2023 - CLICK HERE for the press release
Indication: Familial amyloid polyneuropathy
Cost*: TBD
Key Considerations:
- Granted regulatory approval in the US for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis (ATTRv-PN)
- Only approved treatment for ATTRv-PN that can be self-administered via an auto-injector
- Expected to be commercially available in the US in January 2024
- Granted orphan drug designation
Notable Expanded Indications
Jaypirca® (pirtobrutinib) tablet – expanded to be used for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor
Bivigam® (immune globulin intravenous, human 10% liquid) intravenous injection – expanded to be used for the treatment of pediatric patients two years of age and older with primary humoral immunodeficiency
Cresemba® (isavuconazonium) capsule – expanded for the treatment of invasive aspergillosis and mucormycosis in pediatric patients as young as 12 months of age
Welireg® (belzutifan) tablet – expanded for the treatment of adults with advanced renal cell carcinoma following a PD-1 or PD-L1 inhibitor and a VEGF-TKI
Adbry® (tralokinumab-Idrm) subcutaneous injection – expanded for the treatment of atopic dermatitis in pediatric patients 12 years to 17 years of age
Padcev® (enfortumab vedotin-EJFV) intravenous injection – expanded to be used in combination with pembrolizumab in adults with locally advanced or metastatic urothelial cancer
Biosimilar Approvals
Avzivi® (bevacizumab-tnjn) intravenous infusion
Approval Date: 12/06/2023 - CLICK HERE for the press release
Indication: Certain types of colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, epithelial ovarian, fallopian tube, or primary peritoneal cancer
Additional Information:
- Fifth biosimilar referencing Avastin®
- Launch timeline is being evaluated by the manufacturer, Bio-Thera Solutions
Generic Launches
ProvayBlue® (methylene blue 50mg/10mL) solution
Condylox® (podofilox 0.5%) gel
Lexette® (halobetasol propionate 0.05%) foam
Risperdal Consta® (risperidone extended release 12.5mg, 25mg, 37.5mg, 50mg) intramuscular injection
Contact Us if you'd like to learn more about Capital Rx's full-service pharmacy benefit management (PBM) solutions and clinical programs.
--------
* 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