Capital Rx
Highlights
- Two key new approvals: Ojjaara® for myelofibrosis and Likmez™ for trichomoniasis infections
- Five new notable expanded indications, including for Jardiance® for patients with CKD and Ilaris® for gout flares
- Two notable generic launches and a COVID-19 vaccine update
- Capital Rx's Updated Drug Recall Report: CLICK HERE to review
- Capital Rx's 3Q 2023 Pipeline Report is available
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 September 2023 Monthly Drug Update!
Key New Drug Approvals
Ojjaara® (momelotinib) tablet
Approval Date: 09/15/2023 - CLICK HERE for the press release
Indication: Myelofibrosis
Cost*: $896 per tablet
Key Considerations:
- First and only approved treatment for both newly diagnosed and previously treated patients with myelofibrosis and anemia, including primary or secondary disease
- Once-daily oral tablet for patients with intermediate-or high-risk myelofibrosis
- Orphan drug designation
Likmez™ (metronidazole) oral suspension
Approval Date: 09/22/2023 - CLICK HERE for the press release
Indication: Trichomoniasis infections
Cost*: TBD
Key Considerations:
- First and only metronidazole liquid oral suspension available in the U.S.
- Orphan drug designation
- Approved through the 505(b)(2) New Drug Application pathway using metronidazole as its reference product
Notable Expanded Indications
Jardiance® (empagliflozin 10mg) – expanded to be used to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression
Reblozyl® (luspatercept-aamt) – expanded to treat anemia without previous use of an erythropoiesis stimulating agent use in adults with very low to intermediate risk myelodysplastic syndromes who may require red blood cell transfusions
Mekinist® (trametinib) plus Tafinlar® (dabrafenib) – expanded to treat patients with unresectable or metastatic solid tumors with BRAFV600E mutation that has progressed following prior treatment and with no satisfactory alternative treatment options to include patient one to five years of age
Temodar® (temozolomide) – expanded as an adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma
Ilaris® (canakinumab) – expanded to treat adult patients with gout flares in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate
Generic Launches
Retin-A Micro® (tretinoin 0.08%) gel microsphere pump
Alphagan P® (brimonidine tartrate 0.1%) ophthalmic solution
COVID-19 Updates
On September 11, 2023, the FDA authorized and approved the updated 2023-2024 monovalent XBB.1.5 variant mRNA COVID-19 vaccines by Moderna, Pfizer-BioNTech, and Novavax. CLICK HERE for the announcement.
- These updated 2023-2024 COVID-19 vaccines are recommended to be used in all individuals six months 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