New FDA Approvals: FDA Approves Vtama for AD
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Jan 09, 2025
Dec. 12: The FDA granted another indication to Dermavant Sciences, Inc. subsidiary Organon’s Vtama (tapinarof) for the treatment of atopic dermatitis in people at least 2 years old. The agency first approved the aryl hydrocarbon receptor agonist on May 23, 2022. The cream is applied to affected areas once daily. Drugs.com lists the price of 60 grams as more than $1,531.
Dec. 13: The FDA approved Checkpoint Therapeutics, Inc.’s Unloxcyt (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma or locally advanced CSCC who are not candidates for curative surgery or curative radiation. It is the first programmed death-ligand 1 (PD-L1) inhibitor approved for the second most common form of skin cancer. The agency’s review used the Assessment Aid. Dosing is 1,200 mg via a 30-minute intravenous infusion every three weeks. Checkpoint told Fierce Pharma that it will commercialize Unloxcyt “through one or more potential partnerships or other type of corporate development transaction to enable a potential launch in 2025.”
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