Capital Rx
Highlights
- Five key new approvals, including Suflave™ for colonoscopy prep, Vanflyta® for acute myeloid leukemia, and NgenlaTM for pediatric growth hormone deficiency, among others
- Three notable expanded indications: Leqvio®, Liletta®, and Talzenna®
- Five generic launches: Plasma-Lyte (2), Fleqsuvy®, Aggrastat®, and Mozobil®
- Update 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 July 2023 Monthly Drug Update!
Key New Drug Approvals
SuflaveTM (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, sodium chloride) oral solution
Approval Date: 06/15/2023 - CLICK HERE for the press release
Indication: Cleansing of the colon in preparation for colonoscopy
Cost*: $150 per box
Key Considerations:
- Bowel prep oral solution indicated for colonoscopy preparation in adults
- Taste is similar to a lemon-lime sports drink
- Expected to become available for prescription in August 2023
LitfuloTM (ritlecitinib) tablet
Approval Date: 06/23/2023 - CLICK HERE for the press release
Indication: Treatment for patients 12 years of age and older with severe alopecia areata
Cost*: $135 per tablet
Key Considerations:
- First and only once-daily oral treatment approved by the FDA for adolescents with severe alopecia areata
- Additional indication of Vitiligo currently under review
- Second medication approved for the treatment of alopecia areata
NgenlaTM (somatrogon-ghla) subcutaneous injection
Approval Date: 06/27/2023 - CLICK HERE for the press release
Indication: Pediatric growth hormone deficiency
Cost*: TBD
Key Considerations:
- Long-acting once-weekly treatment for patients three years of age and older who have growth failure due to inadequate secretion of endogenous growth hormone
- Received orphan drug status
- Expected to become available for prescription in August 2023
Opill® (norgestrel) tablet
Approval Date: 07/13/2023 - CLICK HERE for the press release
Indication: Over-the-counter (OTC) status for the prevention of pregnancy
Cost*: TBD
Key Considerations:
- First once-daily birth control tablet available over the counter in the United States without a prescription
- Should be taken at the same time every day to increase efficacy
- Should not be administered as emergency contraception and does not prevent pregnancy after unprotected intercourse or transmission of HIV or other sexually transmitted diseases
Vanflyta® (quizartinib) tablet
Approval Date: 07/20/2023 - CLICK HERE for the press release
Indication: Acute myeloid leukemia
Cost*: $546 per tablet
Key Considerations:
- The first and only FLT3 inhibitor to be approved for the treatment of newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML)
- Up to 37% of newly diagnosed patients with AML have a FLT3 gene mutation, and approximately 80% of these are FLT3-ITD mutations
- To be used in combination with standard cytarabine and anthracycline induction and cytarabine consolidation and as maintenance monotherapy following consolidation chemotherapy
- A REMS program will be in place for possible serious cardiac adverse drug effects
Notable Expanded Indications
Leqvio® (inclisiran) - expanded to be indicated for the treatment of adults with high LDL-C and who are at increased risk of heart disease
Liletta® (levonorgestrel) - expanded to be indicated for the treatment of heavy menstrual bleeding for up to five years in patients who choose intrauterine contraception as their method of contraception
Talzenna® (talazoparib tosylate) - expanded to be used in combination with enzalutamide, indicated for the treatment of adults with homologous recombination repair (HRR) gene-mutated castration-resistant prostate cancer
Generic Launches
Plasma-Lyte148® (electrolyte-148 solution) IV solution
Plasma-Lyte-A® (electrolyte-a solution) IV solution
Fleqsuvy® (baclofen 25mg/5mL) oral suspension
Aggrastat® (tirofiban/nacl 5mg/100mL-0.9%,12.5mg/250mL-0.9%) IV solution
Mozobil® (plerixafor 24mg/1.2mL) SC injection
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