Capital Rx
Highlights
- Ten (10!) key new approvals & six new notable expanded indications
- Two biosimilar approvals: Tofidence™ & Abrilada™ (both for RA and other autoimmune disease indications)
- Two notable generic launches and one COVID-19 vaccine update
- 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 October 2023 Monthly Drug Update!
Key New Drug Approvals
Exxua™ (gepirone) tablet
Approval Date: 09/22/2023 - CLICK HERE for the press release
Indication: Major depressive disorder
Cost*: TBD
Key Considerations:
- First and only oral selective 5HT1a receptor agonist for the treatment of major depressive disorder
- Once-daily tablet for adult patients with major depressive disorder
- Boxed warning for increased risk of suicidal thinking and behavior
Ryzumi™ (phentolamine) ophthalmic solution
Approval Date: 09/25/2023 - CLICK HERE for the press release
Indication: Mydriasis
Cost*: TBD
Key Considerations:
- Treats pharmacologically induced mydriasis produced by adrenergic agonists or parasympathetic agents
Approved in individuals 3 years of age and older - Orphan drug designation
Entyvio® SC (vedolizumab) subcutaneous injection
Approval Date: 09/27/2023 - CLICK HERE for the press release
Indication: Ulcerative colitis
Cost*: TBD
Key Considerations:
- Entyvio® IV must be given for the first two doses prior to switching to SC
- SC injection is dosed every 2 weeks, rather than every 8 weeks with the IV dosage
Pombiliti™ (cipaglucosidase alfa-atgo) intravenous infusion + Opfolda™ (miglustat) capsule
Approval Date: 09/28/2023 - CLICK HERE for the press release
Indication: Late-onset Pompe disease
Cost*: $650,000 per year
Key Considerations:
- First and only two-component therapy for late-onset Pompe disease in adults weighing >40 kg who are not improving on enzyme replacement therapy
- Orphan drug designation
- Pombiliti has a boxed warning for hypersensitivity reactions including anaphylaxis, infusion-associated reactions, and risk of acute cardiorespiratory failure
Rivfloza™ (nedosiran) subcutaneous injectionntyvio® SC (vedolizumab) subcutaneous injection
Approval Date: 09/29/2023 - CLICK HERE for the press release
Indication: Lower urinary oxalate levels
Cost*: TBD
Key Considerations:
- Once-monthly injection to lower urinary oxalate levels in individuals 9 years of age and older with primary hyperoxaluria type 1
- Orphan drug designation
Velsipity™ (estrasimod) tablet
Approval Date: 10/12/2023 - CLICK HERE for the press release
Indication: Ulcerative colitis
Cost*: $205 per tablet
Key Considerations:
- Once-daily tablet to treat moderate to severe ulcerative colitis in adults
- First-line advanced treatment option with no boxed warnings
Zilbrysq® (zilucoplan) subcutaneous injection
Approval Date: 10/17/2023 - CLICK HERE for the press release
Indication: Myasthenia gravis
Cost*: TBD
Key Considerations:
- Once-daily subcutaneous injection to treat generalized myasthenia gravis (gMG) is adult patients who are anti-acetylcholine receptor (AChR) antibody positive
- Orphan drug designation
- Only available through the Zilbrysq Risk Evaluation and Mitigation Strategy (REMS) program due to risk of meningococcal infections
Xphozah® (tenapanor) tablet
Approval Date: 10/17/2023 - CLICK HERE for the press release
Indication: Hyperphosphatemia
Cost*: TBD
Key Considerations:
- The first and only approved phosphate absorption inhibitor
- Twice-daily tablet to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis
- Add-on therapy to patients who have an inadequate response to phosphate binders or are intolerant to phosphate binder therapy
Bimzelx™ (bimekizumab-bkzx) subcutaneous injection
Approval Date: 10/17/2023 - CLICK HERE for the press release
Indication: Plaque psoriasis
Cost*: TBD
Key Considerations:
- The first and only approved IL-17A and IL-17F inhibitor for treatment of adults with moderate to severe plaque psoriasis
- Subcutaneous injection that is dosed every 8 weeks, but may be dosed more frequently (every 4 weeks) in individuals weighing > 120 kg
Qlosi™ (pilocarpine) ophthalmic solution
Approval Date: 10/17/2023 - CLICK HERE for the press release
Indication: Presbyopia
Cost*: TBD
Key Considerations:
- Up to twice-daily eye drop for presbyopia with effect lasting up to 8 hours
- Low-dose, preservative-free eye drop
Notable Expanded Indications
Bosulif® (bosutinib) – expanded to treat pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy
Veltassa® (patiromer) – expanded to treat pediatric patients 12 years of age and older with hyperkalemia
Zoryve® (roflumilast) – expanded to treat pediatric patients 6 years of age and older with plaque psoriasis
Braftovi® (encorafenib) – expanded to use in combination with binimetinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test
Mektovi® (binimetinib) – expanded to use in combination with encorafenib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test
Voxzogo® (vosoritide) – expanded to increase linear growth in pediatric patients under 5 years of age with achondroplasia with open epiphyses
Biosimilar Approvals
Tofidence™ (tocilizumab-bavi) intravenous infusion
Approval Date: 09/29/2023 - CLICK HERE for the press release
Indication: Rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis
Additional Information:
- First biosimilar referencing Actemra®
- Launch timeline is being evaluating by the manufacturer, Biogen
Abrilada™ (adalimumab-afzb) subcutaneous injection
Approval Date: 10/04/2023 - CLICK HERE for the press release
Indication: Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis, plaque psoriasis, and uveitis
Additional Information:
- Granted interchangeable designation – now one of only two biosimilars that are interchangeable with Humira®
Interchangeable designation supported by positive data from the REFLECTIONS B538-12 study
Generic Launches
Onexton® (clindamycin phosphate-benzoyl peroxide 1.2-3.75%) gel
Mydayis® (amphetamine-dextroamphetamine 3-bead cap ER 24 hr, 12.5 mg, 25 mg, 37.5 mg, 50 mg) capsule
COVID-19 Updates
On October 3, 2023, the FDA authorized and approved the adjuvant 2023-2024 COVID-19 vaccine by Novavax in individuals 12 years of age and older.
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