Clinical Content & Reports

Drug Pipeline & Clinical Update - October 2023

November 10, 2023

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:

Ryzumi™ (phentolamine) ophthalmic solution

Approval Date: 09/25/2023 - CLICK HERE for the press release

Indication: Mydriasis

Cost*: TBD

Key Considerations:

Entyvio® SC (vedolizumab) subcutaneous injection

Approval Date: 09/27/2023 - CLICK HERE for the press release

Indication: Ulcerative colitis

Cost*: TBD

Key Considerations:

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:

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:

Velsipity™ (estrasimod) tablet

Approval Date: 10/12/2023 - CLICK HERE for the press release

Indication: Ulcerative colitis

Cost*: $205 per tablet

Key Considerations:

Zilbrysq® (zilucoplan) subcutaneous injection

Approval Date: 10/17/2023 - CLICK HERE for the press release

Indication: Myasthenia gravis

Cost*: TBD

Key Considerations:

Xphozah® (tenapanor) tablet

Approval Date: 10/17/2023 - CLICK HERE for the press release

Indication: Hyperphosphatemia

Cost*: TBD

Key Considerations:

Bimzelx™ (bimekizumab-bkzx) subcutaneous injection

Approval Date: 10/17/2023 - CLICK HERE for the press release

Indication: Plaque psoriasis

Cost*: TBD

Key Considerations:

Qlosi™ (pilocarpine) ophthalmic solution

Approval Date: 10/17/2023 - CLICK HERE for the press release

Indication: Presbyopia

Cost*: TBD

Key Considerations:

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:

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:

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.

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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

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