Capital Rx
Highlights
- Four key new drug approvals, including Emrosi™ for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults
- Three notable expanded indications, including Jylamvo™ - expanded to include the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA)
- One biosimilar approval for Stendra™ (avanafil 50 mg, 100 mg, 200 mg) tablet
- 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 2024 Monthly Drug Update!
Key New Drug Approvals
Orlynvah™ (sulopenem etzadroxil and probenecid) tablet
Approval Date: 10/25/2024
Indication: Treatment of uncomplicated urinary tract infections (UTI) in adult women who have limited or no alternative oral antibacterial treatment options
Cost*: TBD
Key Consideration:
• First oral penem antibiotic approved in the U.S.
• Received priority review
• Dosed orally twice daily for a 5-day course of therapy
• Expected to compete with nitrofurantoin, fosfomycin, and Pivya™ (pivmecillinam)
Press Release: https://www.iterumtx.com/news/press-releases/detail/136/iterum-therapeutics-receives-u-s-fda-approval-of
Emrosi™ (minocycline) extended-release capsule
Approval Date: 11/4/2024
Indication: Treatment of inflammatory lesions (papules and pustules) of rosacea in adults
Cost*: TBD
Key Consideration:
• Approved via FDA 505(b)(2) pathway
• Recommended dosage is 40 mg orally once daily
• Expected to compete with generic minocycline, generic doxycycline, and tetracycline oral antibiotic products on the market
Danziten™ (nilotinib) tablet
Approval Date: 11/7/2024
Indication: Treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase; Treatment of adult patients with chronic phase and accelerated phase Ph+ CML resistant to or intolerant to prior therapy that included imatinib
Cost*: TBD
Key Consideration:
• Approved via FDA 505(b)(2) pathway referencing Novartis’ Tasigna™
• Recommended dosage varies based on indication; dosed orally twice daily
• New formulation that does not require the same mealtime restrictions as Tasigna™
Revuforj™(revumenib) tablet
Approval Date: 11/15/2024
Indication: Treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older
Cost*: $39,500 per month
Key Consideration:
• FDA granted Breakthrough Therapy, Fast Track Designation, and Priority Review
• First and only menin inhibitor; dosed orally twice daily on an empty stomach or with a low-fat meal
• KMT2A generic abnormality is found in about 10% of acute leukemias
Press Release: https://ir.syndax.com/news-releases/news-release-details/syndax-announces-fda-approval-revuforjr-revumenib-first-and-only
Notable Expanded Indications
• Abrysvo™ (respiratory syncytial virus vaccine) – expanded indication for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV
• Jylamvo™ (methotrexate) oral solution – expanded to include the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA)
• Scemblix™ (asciminib) – expanded indication for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP)
Generic Launches
• Stendra™ (avanafil 50 mg, 100 mg, 200 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.
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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