Clinical Content & Reports

Drug Pipeline & Clinical Update - August 2023

September 5, 2023

Capital Rx


  • Five key new approvals, including AkeegaTM for prostate cancer, ZurzuvaeTM for postpartum depression, and Xdemvy® for demodex blepharitis
  • One biosimilar approval: Tyruko® for MS (biosimilar to Tysabri®)
  • Two notable expanded indications, two pipeline updates, and seven 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 August 2023 Monthly Drug Update!

Key New Drug Approvals

Xdemvy® (lotilaner) ophthalmic solution

Approval Date: 07/25/2023 - CLICK HERE for the press release

Indication: Demodex blepharitis

Cost*: $1,850 per 6-week treatment

Key Considerations:

RiVive™ (naloxone) nasal spray

Approval Date: 07/28/2023 - CLICK HERE for the press release

Indication: Known or suspected opioid overdose emergency

Cost*: TBD

Key Considerations:

Zurzuvae™ (zuranolone) capsule

Approval Date: 08/4/2023 - CLICK HERE for the press release

Indication: Postpartum depression

Cost*: TBD

Key Considerations:

Akeega™ (niraparib and abiraterone acetate) tablet

Approval Date: 08/11/2023 - CLICK HERE for the press release

Indication: BRCA-positive metastatic castration-resistant prostate cancer

Cost*: $625 per tablet

Key Considerations:

Sohonos™ (palovarotene) capsule

Approval Date: 08/16/2023 - CLICK HERE for the press release

Indication: Fibrodysplasia ossificans progressiva

Cost*: $1,710 per capsule

Key Considerations:

Biosimilar Approvals

Tyruko® (natalizumab-sztn) intravenous injection

Approval Date: 08/25/2023 - CLICK HERE for the press release

Indication: Biosimilar to Tysabri® (natalizumab) indicated for the treatment of multiple sclerosis and Crohn’s disease

Additional Information:

Generic Launches

Symbicort® (Breyna, budesonide-formoterol fumarate dihyd 80-4.5 mcg/act, 160-4.5mcg/act) aerosol

Onglyza® (saxagliptin 2.5mg, 5mg) tablet

Kombiglyze XR® (saxagliptin-metformin 2.5-1000mg, 5-500mg, 5-1000mg) extended-release tablet

Spiriva Handihaler® (tiotropium 18mcg) inhaled capsule

Trionex® (calcipotriene 0.005%) cream dressing kit

Balcoltra® (levonorgestrel-ethinyl estradiol-fe 0.1mg-20mcg) tablet

Vyvanse® (lisdexamfetamine 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, 70mg) capsules and chewable tablets

Notable Expanded Indications

Lonsurf® (tipiracil/trifluridine)- expanded to be used in combination with bevacizumab indicated for the treatment of metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type

Ingrezza® (valbenazine)-expanded to treat Chorea associated with Huntington's disease

Notable Pipeline Medication Updates

Beyfortus™ (nirsevimab-alip) subcutaneous injection

Approval Date: 07/17/2023 - CLICK HERE for the press release

Indication: Prevention of serious lower respiratory tract disease due to respiratory syncytial virus (RSV)

Cost*: $594 per vial

Key Considerations:

Abrysvo™ (Respiratory Syncytial Virus Vaccine) subcutaneous injection

Approval Date: 08/21/2023 - CLICK HERE for the press release

Indication: Respiratory syncytial virus (RSV)

Cost*: $354 per dose

Key Considerations:

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

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