Capital Rx
Highlights
- Ten key new approvals, including Ixchiq®, a new vaccine for the Chikungunya virus, and Lilly's Zepbound™, for chronic weight management
- Six new notable expanded indications including Xtandi® for prostate cancer and Orencia® for active psoriatic arthritis
- One biosimilar approval: Wezlana™, the first biosimilar referencing Stelara®
- Four notable 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 November 2023 Monthly Drug Update!
Key New Drug Approvals
Omvoh® (mirikizumab) intravenous then subcutaneous
Approval Date: 10/26/2023 - CLICK HERE for the press release
Indication: Moderate to severe active ulcerative colitis
Cost*: $144,000 annually
Key Considerations:
- First-in-class treatment for adults with moderate to severe active ulcerative colitis
- Administered by a healthcare professional intravenously once a week every four weeks for a total of three infusions and transition to two subcutaneous self-injections every four weeks during maintenance treatment
Agamree® (vamorolone) oral suspension
Approval Date: 10/26/2023 - CLICK HERE for the press release
Indication: Duchenne Muscular Dystrophy (DMD)
Cost*: TBD
Key Considerations:
- Once daily oral treatment of DMD in patients two years of age and older
- Granted orphan drug and rare pediatric disease designation status
Voquezna® (vonoprazan) tablet
Approval Date: 11/01/2023 - CLICK HERE for the press release
Indication: Erosive esophagitis, erosive GERD, and relief of heartburn
Cost*: $26 per tablet
Key Considerations:
- Novel oral tablet for the treatment in adults with all grades of erosive esophagitis, maintenance of healing all grades of erosive gastroesophageal reflux disease (GERD), and relief of heartburn associated with erosive GERD
- Expected to become available in the U.S. market in December 2023
Zituvimet™ (sitagliptin/metformin) tablet
Approval Date: 11/03/2023 - CLICK HERE for the press release
Indication: Type 2 diabetes
Cost*: TBD
Key Considerations:
- Fixed-dose combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
- Not recommended in patients with type 1 diabetes or in patients with a history of pancreatitis
Zepbound™ (tirzepatide) subcutaneous injection
Approval Date: 11/08/2023 - CLICK HERE for the press release
Indication: Chronic weight management
Cost*: $1,060 per box (4 syringes)
Key Considerations:
- Indicated as an adjunct to diet and exercise for chronic weight management in adults with a BMI of greater than 30 or greater than 27 with at least one weight-related comorbidity such as high blood pressure, type 2 diabetes, or high cholesterol
- Black box warning for the risk of thyroid tumors due to preclinical findings in rats, although not clear if that risk is also present for humans
Fruzaqla™ (fruquintinib) capsule
Approval Date: 11/08/2023 - CLICK HERE for the press release
Indication: Metastatic colorectal cancer
Cost*: TBD
Key Considerations:
- First and only selective inhibitor of all three VEGF receptor kinases approved for previously treated metastatic colorectal cancer regardless of biomarker status
- Indicated as an oral targeted therapy for adults with metastatic colorectal cancer in patients who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy
- Received priority review
Ixchiq® (chikungunya vaccine, live) intramuscular injection
Approval Date: 11/09/2023 - CLICK HERE for the press release
Indication: Chikungunya
Cost*: TBD
Key Considerations:
- First vaccine approved to prevent disease caused by Chikungunya virus in adults 18 years of age and older who are at increased risk of exposure to the chikungunya virus
- A single-dose, live-attenuated vaccine which received priority review from the FDA
- Approved under accelerated approval based on anti-chikungunya neutralizing antibody titers
- Administered as a single intramuscular 0.5mL dose by a healthcare provider
Augtyro™ (repotrecitnib) capsule
Approval Date: 11/15/2023 - CLICK HERE for the press release
Indication: Non-small cell lung cancer
Cost*: $29,000 monthly
Key Considerations:
- Indicated to treat adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer
- Dosed as 160mg once daily for 14 days, then increase to 160mg twice daily with or without food
- Expected to become available in the U.S. in mid-December 2023
Truqap™ (capivasertib) tablet
Approval Date: 11/16/2023 - CLICK HERE for the press release
Indication: Hormone receptor-positive breast cancer
Cost*: TBD
Key Considerations:
- First-in-class oral adenosine triphosphate competitive inhibitor that offers a new targeted treatment for breast cancer administered twice daily according to an intermittent dosing schedule of four days on and three days off
- Administered in combination with Faslodex® for the treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer with one or more biomarker alterations, as detected by an FDA-approved test
- Granted priority review
Ogsiveo™ (nirogacestat) tablet
Approval Date: 11/27/2023 - CLICK HERE for the press release
Indication: Desmoid tumors
Cost*: TBD
Key Considerations:
- First and only treatment of adult patients with progressing desmoid tumors who require systemic treatment
- Granted breakthrough therapy, fast track, and orphan drug designation
Notable Expanded Indications
Xtandi® (enzalutamide) capsule – expanded to be used for non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis
Vabysmo® (faricimab-svoa) – expanded to be used for the treatment of macular edema following retinal vein occlusion
Cosentyx® (secukinumab) – expanded to be used for the treatment of adults with moderate to severe hidradenitis suppurativa
Idacio® (adalimumab-aacf) – expanded to be used for the treatment of noninfectious intermediate, posterior and panuveitis in adult patients
Orencia® (abatacept) – expanded to be used for the treatment of active psoriatic arthritis to include pediatric patients ≥ 2 years of age
Keytruda® (pembrolizumab) – expanded as an adjuvant treatment with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma(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
Biosimilar Approvals
Wezlana™ (ustekinumab-auub) intravenous infusion/subcutaneous
Approval Date: 10/31/2023 - CLICK HERE for the press release
Indication: Plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis
Additional Information:
- First biosimilar referencing Stelara®
- Received interchangeable approval
- Launch timeline is being evaluated by the manufacturer, Amgen, with a date no later than January 1, 2025
Generic Launches
CaroSpir® (spironolactone 25mg/5mL) suspension
Livalo® (pitavastatin 1mg, 2mg, 4mg) tablet
Mitigare® (colchicine 0.6mg) capsule
Forteo® (teriparatide 20mcg) injection
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