Vtama Gets Atopic Dermatitis Indication
On Dec. 13, 2024, the US Food and Drug Administration (FDA) approved Vtama® (tapinarof – Organon) cream 1% for the topical treatment of atopic dermatitis (AD) in adults and pediatric patients two years of age and older. Atopic dermatitis is a common form of eczema, a group of chronic skin diseases that involve inflammation and cause itchy, irritated bumps, crusts, and scales on the skin. It usually begins in childhood, with most patients having a first episode before the age of five years. More than nine million children and 16 million adults in the US have AD. Symptoms may improve and worsen unpredictably. An aryl hydrocarbon receptor (AhR) agonist originally approved for psoriasis in 2022, Vtama works differently than topical corticosteroids, interfering with the inflammatory effects of interleukin-17 (IL-17) to help restore normal skin cell turnover. To treat atopic dermatitis, it is applied sparingly once a day to the affected skin, including sensitive areas such as the armpits, face, and external genitals. It should not be used in the eyes, mouth, or internal genitals, however. Unlike steroids, which should be used only for short periods, Vtama has no limits on how long it can be applied. Prescribing information may be found here.
New Indication for Nemluvio
Galderma announced on Dec. 14, 2024, that the FDA approved Nemluvio® (nemolizumab) for patients 12 years and older with moderate-to-severe atopic dermatitis to be used in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies. Originally approved in August 2024 for prurigo nodularis, Nemluvio is an interleukin-31 (IL-31) receptor antagonist that prevents itch, inflammation, and epidermal dysregulation. Studies showed significant improvement in skin clearance after 16 weeks of treatment. The recommended dose is an initial 60mg subcutaneous (SC) injection (two 30mg injections), followed by 30mg given every four weeks. If at 16 weeks of treatment, patients achieve clear or almost clear skin, they may take an SC dose of 30mg every eight weeks. Patients must complete all age-appropriate immunizations prior to starting treatment and use Nemluvio with TCS and TCI until the disease has sufficiently improved. Here is the prescribing information.
Celltrion’s Stelara Biosimilar Approved
The FDA approved Celltrion’s Steqeyma® (ustekinumab-stba), the seventh Stelara® (ustekinumab – Johnson & Johnson Innovative Medicine) biosimilar on Dec. 17, 2024. Steqeyma, which will be available in subcutaneous (SC) and intravenous (IV) formulations, is approved for the treatment of adults with Crohn’s disease (CD) and ulcerative colitis (UC), and adult and pediatric patients with plaque psoriasis and psoriatic arthritis (PsA). By inhibiting interleukins 12 and 23 (IL-12 and IL-23), ustekinumab interrupts processes involved in chronic inflammation and immune responses. Steqeyma will be marketed in the US under a settlement agreement that allows its release for sale no later than Feb. 22, 2025. Several biosimilars to Stelara are expected to launch early next year, including FDA-approved Wezlana™ (ustekinumab-auub – Amgen), Selarsdi™ (ustekinumab-aekn – Alvotech/Teva), Pyzchiva™ (ustekinumab-ttwe – Sandoz), Otulfi™ (ustekinumab-aauz –Fresenius Kabi and Formycon), Imuldosa™ (ustekinumab-srlf – Don-A ST/Accord) and Yesintek™ (ustekinumab-kfce – Biocon). For complete prescribing information, please look here.
MedWatch Update
FDA Adds Boxed Warning to Veozah
On Dec. 16, 2024, the FDA announced the addition of a Boxed Warning to highlight the risk of rare but serious liver injury associated with the use of Veozah® (fezolinetant – Astellas). Veozah is a non-hormonal drug that was approved in 2023 to treat moderate-to-severe vasomotor symptoms (hot flashes and night sweats) associated with menopause. A post marketing case showed serious liver injury in a patient within 40 days of starting Veozah that slowly reversed upon stopping the medication. The package insert now also recommends increasing the frequency of liver blood testing to monthly for the first two months after beginning therapy, followed by months three, six, and nine of treatment as already recommended. If signs and symptoms of liver injury occur, the patient should stop the medicine immediately and contact their prescriber. The updated prescribing information is here.
Updates for the GLP-1/GIP Compounding Market Snapshot Issues Document
Many online companies capitalized on customer interest in semaglutide and tirzepatide for weight loss and began offering telehealth prescribing of the compounded versions of these medications while they were in shortage. Tirzepatide was removed from the shortage list, meaning compounders must stop producing it; however, a first-of-its-kind lawsuit was filed against the FDA. After two months, the FDA re-reviewed its decision and confirmed that the tirzepatide shortage was resolved. Compounding pharmacies must cease tirzepatide compounds by Feb. 18, 2024, and outsourcing facilities must cease by March 19, 2024. Updates to this previously published document can be found on OCEP’s SharePoint site.