Capital Rx
Highlights
- 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:
- First and only approved treatment for the diagnosis of demodex blepharitis
- Instill one drop into each eye twice daily, approximately 12 hours apart, for six weeks
- Expected to become available for prescription in August 2023
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:
- Second over-the-counter (OTC) naloxone nasal spray approved for the emergency treatment of known or suspected opioid overdose
- Received priority review
- Approved through the 505(b)(2) New Drug Application pathway using Naloxone as its reference product
Zurzuvae™ (zuranolone) capsule
Approval Date: 08/4/2023 - CLICK HERE for the press release
Indication: Postpartum depression
Cost*: TBD
Key Considerations:
- First and only oral treatment approved for adults with postpartum depression
- Once-daily 14-day treatment that should be taken in the evening with a fatty meal
- Granted priority review and fast track designation
- Boxed warning for driving impairment due to central nervous system depressant effects
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:
- First dual-action combination oral tablet that is indicated for metastatic castration-resistant prostate cancer in individuals who are BRCA 1/2 positive
- Approved to be used in combination with prednisone
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:
- The first and only treatment for fibrodysplasia ossificans progressiva
- Retinoid indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients 8 years of age and older for females and 10 years of age and older for males
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:
- Due to patent litigation, launch timeframe is unknown
- Manufactured by Sandoz
- Boxed warning to inform health care professionals and patients about the increased risk of progressive multifocal leukoencephalopathy
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:
- One dose of Beyfortus, administered as a single intramuscular injection prior to or during RSV season, may provide protection during the RSV season
- Indicated for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season
- Regular RSV season takes place from November-March
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:
- First and only U.S. approval of a maternal vaccine for pregnant individuals at 32 through 36 weeks gestational age to help protect infants at birth through six months of life from lower respiratory tract disease (LRTD) and severe LRTD due to RSV
- Also indicated for the prevention of LRTD caused by RSV in people 60 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