The dermatology space has seen many FDA approvals and expansions in 2024.
Healio has compiled a list of the most-read articles about these approvals over the past year.
FDA approves Zelsuvmi for molluscum contagiosum
A topical antiviral gel, Zelsuvmi (berdazimer gel 10.3%, Ligand Pharmaceuticals) releases nitric oxide upon application and has an antimicrobial effect. It is the first prescription treatment indicated for the viral skin infection that mostly affects children. Read more.
FDA approves Xeomin as first neurotoxin for simultaneous treatment of facial lines
Previously approved in 2011 for the temporary improvement of moderate to severe glabellar frown lines, the indication of Xeomin (incobotulinumtoxinA, Merz Aesthetics) was expanded to also include forehead lines and crow's feet. Read more.
FDA expands Klisyri approval for actinic keratosis treatment on larger face, scalp areas
Klisyri (tirbanibulin, Almirall) 1%, a microtubule inhibitor ointment, was originally approved in December 2020 for the treatment of extensive actinic keratosis manifestations up to 25 cm on the face and scalp. The expanded approval now allows the drug's utility up to 100 cm on these affected areas. Read more.
FDA approves Zoryve for atopic dermatitis in adults, children
Zoryve (roflumilast, Arcutis) cream 0.15% is a steroid-free, once-daily, topical phosphodiesterase 4 inhibitor. In its various formulations, roflumilast has been approved for both plaque psoriasis and seborrheic dermatitis, making atopic dermatitis its third indication. Rad more.
FDA approves Selarsdi as Stelara biosimilar for psoriasis, psoriatic arthritis
Selarsdi (ustekinumab-aekn, Teva Pharmaceuticals/Alvotech) injection is now approved for subcutaneous use as an interchangeable biosimilar to Stelara (ustekinumab, Janssen) for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and patients aged at least 6 years. Read more.
FDA approves oral JAK inhibitor Leqselvi for severe alopecia areata in adults
The approval was supported by data from two multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, and two open-label, long-term extension trials. Read more.
FDA approves pediatric indication for NexoBrid for treatment of thermal burns
Originally approved in 2022 for eschar removal of deep partial-thickness and full-thickness thermal burns in adults only, NexoBrid (anacaulase-bcdb, Vericel Corporation) is now indicated in the pediatric population as well. Read more.
'Another arrow to the quiver for physicians': FDA approves Emrosi for rosacea
Previously known as DFD-29, Emrosi (Journey Medical Corporation/Dr. Reddy's Laboratories) is a 40 mg minocycline hydrochloride extended-release capsule for the treatment of this inflammatory skin condition. Read more.
FDA approves Sofdra gel for primary axillary hyperhidrosis
Characterized by excessive underarm sweating, hyperhidrosis can be a socially, mentally and sometimes physically debilitating condition. As the third largest dermatology condition in U.S., hyperhidrosis can not only affect a patient's ability to work productively and participate in daily routine activities, but it can also greatly impact patients' relationships and mental states. Read more.
FDA approves Bimzelx for adults with moderate to severe hidradenitis suppurativa
This approval makes Bimzelx (bimekizumab-bkzx, UCB) the first and only approved interleukin-17F and -17A inhibitor in this indication, providing another much-needed treatment in dermatologists' armamentarium. Read more.