Dermatology in 2024: FDA First Half Recap, with James Del Rosso, DO

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Our dermatology FDA recap for the first half of 2024 includes our top 5 approvals, 3 decisions to watch in the second half of 2024, and a podcast episode with James Del Rosso, DO

Led by a flood of biologic therapies becoming available and others progressing within the therapeutic pipeline, the field of dermatology finds itself in the midst of a watershed moment for a slew of dermatologic conditions. To celebrate and recap the advancements occurring in the first half of 2024, the editorial team of HCPLive Dermatology sat down with James Del Rosso, DO, research director of JDR Dermatology Research and president of the American Acne and Rosacea Society, for more perspective on pipeline movement.

Del Rosso, who also serves as an adjunct clinical professor of Dermatology at Touro University, takes a deep dive into several different disease states in dermatology and highlights how the news to emerge in the last 6 months, as well as prior to the close of 2023, has influenced real-world management. In our summary below, we spotlight some of the biggest FDA approvals from 2024 so far as well as highlighting key submissions and forthcoming regulatory decisions.

Top 5 Approvals

FDA Approves Topical Berdazimer Gel for Molluscum Contagiosum

On January 05, 2024, the field of dermatology welcomed the second FDA approved agent for molluscum contagiosum with the approval of bedazimer gel. Billed as the first novel drug formulated for the treatment of molluscum infections, as well as it is the first and the only topical drug applicable by caregivers or patients themselves.

FDA Updates Dupilumab Label Supporting Use Among Atopic Dermatitis Patients with Hand, Foot Involvement

On January 16, 2024, Regeneron Pharmaceuticals and Sanofi announced the FDA had approved a label update for dupilumab (Dupixent) to support use in atopic dermatitis among patients hand or foot involvement. According to the companies, the agency’s decision to revise the labeling for dupilumab followed the phase 3 findings from the LIBERTY-AD-HAFT study.

Spesolimab Approved in US, China for Generalized Pustular Psoriasis in Patients 12 and Older

On March 19, 2024, Boehringer Ingelheim announced the FDA’s approval of a label expansion for spesolimab (Spevigo) injection to include treatment of generalize pustular psoriasis among patients aged 12 years and older weighing at least 40 kg.

“Until now, people living with GPP have not had any approved options to treat their disease,” Bruce Strober, MD, PhD, clinical professor of dermatology at Yale University and Central Connecticut Dermatology, said in a statement. “(Spesolimab) has the potential to redefine the treatment options for the patients we serve.”

FDA Approves Tirbanibulin for Actinic Keratosis on Larger Areas of Face, Scalp

On June 10, 2024, Almirali announced the FDA had expanded the indication for tirbanibulin (Klisyri) for the treatment of actinic keratosis for larger areas of the face and scalp. The approval expands the potential treatment area for tirbanibulin by 4 times from 25 cm2 to 100 cm2. In addition to the expanded label, the company also announced an increased package size of 350 mg.

FDA Approval of Single-Dose Tralokinumab Autoinjector for Adults with Atopic Dermatitis

On June 13, 2024, LEO Pharma announced the FDA approval of a 300 mg single-dose auto injector for tralkokinumab (Adbry) for use in adults with moderate-to-severe atopic dermatitis. Tralokinumab had previously been available only via a single, pre-filled, 150 mg/1 mL syringe and this new option offers greater flexibility for patients, according to LEO Pharma.

Key Submissions to Watch

FDA Accepts Tapinarof Cream sNDA for Atopic Dermatitis Patients Aged 2 Years and Older

On April 29, 2024, Dermavant Sciences announced the FDA’s acceptance of their sNDA for tapinarof cream (Vtama) for the treatment of atopic dermatitis in both adults and children aged 2 years and older. According to the company’s announcement, the application is based on the ADORING 1 and ADORING 2 trials as well as data from an open-label pharmacokinetics trial and the FDA assigned a PDUFA date in Q4 2024.

Biologics License Application for Nemolizumab Accepted by FDA for Prurigo Nodularis, Atopic Dermatitis

On February 19, 2024, Galderma announced the of its BLA for nemolizumab for the treatment of prurigo nodularis and for adolescents and adults with moderate to severe atopic dermatitis. According to Galderma, its applications for atopic dermatitis and prurigo nodularis, the latter of which received a Priority Review designation, are based on data from the OLYMPIA and ARCADIA clinical programs, respectively.

Lebrikizumab for Atopic Dermatitis Resubmitted for FDA Approval After Previous Rejection

On April 30, 2024, the dermatology community received its latest update on lebrikizumab. Eli Lilly and Company announced it had resubmitted its application for lebrikizumab in the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis following the receipt of a CRL in October 2023, which the company said was based on findings from multi-sponsor inspection of a third-party, contract manufacturing organization. According to the October 2023 announcement, the FDA expressed no concerns about the clinical data package, safety or label for lebrikizumab and a decision is expected in Q4 2024.

Relevant disclosures for Del Rosso include Allergan, Galderma, Bayer, Dermira, Promius, Ranbaxy, Taro, Sebacea, Suneva, Valeant, Aqua, LeoPharma, Merz, Anacor, Purcap, Unilever, and Ferndale.