Capital Rx
Highlights
- Three key new drug approvals, including Ojemda™ (torarafenib) for pLGG, the most common brain tumor diagnosed in children
- Three notable expanded indications, including Fanapt® (iloperidone) for acute treatment of bipolar I disorder
- One Biosimilar approval and two 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 April 2024 Monthly Drug Update!
Key New Drug Approvals
Voydeya™ (danicopan) tablet
Approval Date: 04/01/2024 - CLICK HERE for the press release
Indication: Treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH) as add-on therapy to ravulizumab or eculizumab
Cost*: $50,261 annually
Key Considerations:
- Orphan drug designation
- First-in-class oral, Factor D inhibitor
Ojemda™ (torarafenib) tablet; suspension
Approval Date: 04/23/2024 - CLICK HERE for the press release
Indication: Treatment of relapsed or refractory pediatric low-grade glioma (LGG) with BRAF mutation in patients 6 months of age or older
Cost*: $1,211 per tablet
Key Considerations:
- First and only FDA approved type II RAF inhibitor for indication
- Once weekly, oral dose with or without food
- Received pediatric disease priority review
- Orphan drug designation
Duvyzat™ (givinostat) oral suspension
Approval Date: 04/24/2024 - CLICK HERE for the press release
Indication: Treatment of uncomplicated urinary tract infection (UTI)
Cost*: TBD
Key Considerations:
- Received priority review
- Expected to be available in 2025
Notable Expanded Indications
Fanapt® (iloperidone) tablet – expanded to be used for acute treatment of bipolar I disorder
Dovato® (dolutegravir; lamivudine) tablet – expanded to be used for the treatment of HIV-1 infection in patients 12 years of age and older, weight at least 25 kg with no antiviral treatment history or to replace current antiretroviral regimen in those who are virologically suppressed with no history of treatment failure
Alecensa® (alectinib) capsule – expanded to be used as adjuvant treatment following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC)
Biosimilar Approvals
Selarsdi™ (ustekinumab-aekn) subcutaneous injection
Approval Date: 04/16/2024 - CLICK HERE for the press release
Indication: Treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in patients 6 years and older
Additional information:
- Biosimilar to Stelara®
- 80% chance of launch in the market after February 2025
Generic Launches
Oracea® (doxycycline delayed release 40 mg) capsule
Myrbetriq® (mirabegron ER 24h 25 mg) tablet
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