2024 Drug Approvals in Review: Part 1

2024 was filled with approvals for a number of conditions, such as atopic dermatitis, psoriasis, and prurigo nodularis. To keep up with approvals from the year, review part 1 of our comprehensive recap below, and keep an eye out for our coverage of what is to come in 2025.

January 5, 2024: FDA Approves Berdazimer Gel, 10.3% for the Treatment of Molluscum Contagiosum

The FDA approved Ligand Pharmaceuticals' berdazimer gel (10.3%) for the treatment of molluscum contagiosum in patients aged 1 year and older, making it the second FDA-approved therapy for this condition after Verrica Pharmaceuticals' Ycanth. Berdazimer gel, marketed as Zelsuvmi, represented a significant advancement as the first efficacious topical prescription medication for molluscum that can be applied by patients or caregivers. The approval followed positive results from the phase 3 B-SIMPLE4 trial, which showed significant improvement in lesion clearance by week 12, with minimal adverse events such as mild application site pain and erythema.

January 16, 2024: FDA Updates Dupilumab Label With Hand, Foot Atopic Dermatitis Involvement

The FDA approved a label update for Regeneron and Sanofi’s dupilumab (Dupixent), extending its use to patients aged 12 and older with uncontrolled moderate to severe atopic dermatitis (AD) involving the hands and/or feet. This update was based on results from the phase 3 LIBERTY-AD-HAFT trial, the first study to evaluate a biologic in this patient group. The trial demonstrated that by week 16, 40% of patients treated with dupilumab achieved clear or almost clear skin on their hands and feet, compared to 17% with placebo, and 52% experienced significant itch reduction, compared to 14% with placebo. Safety outcomes were consistent with dupilumab’s established profile, with common adverse events being mild. Dupixent's revised label was also approved in the EU, with additional regulatory submissions underway globally.

February 19, 2024: Lifileucel Receives FDA Accelerated Approval for Advanced Melanoma

The FDA granted accelerated approval to Iovance Biotherapeutics’ lifileucel (Amtagvi), a 1-time personalized T-cell therapy, for adults with unresectable or metastatic melanoma after prior PD-1 blocker and, if applicable, BRAF/MEK inhibitor treatment. Based on phase 2 C-144-01 trial data, 31.5% of patients achieved a response, with 43.5% maintaining it beyond 12 months. Lifileucel, the first T-cell therapy approved for solid tumors, uses tumor-infiltrating lymphocytes (TIL cells) to target cancer. While highly promising, it carries risks such as severe cytopenia and infections.

March 5, 2024: FDA Approves Juvederm as the First and Only Hyaluronic Acid Dermal Filler for Use in Moderate to Severe Temple Hollowing

The FDA approved Juvéderm Voluma XC, the first hyaluronic acid dermal filler for use in the upper face, specifically to treat moderate to severe temple hollows in adults aged 21 and older. In clinical trials, over 80% of patients saw significant improvement in temple hollowing within 3 months, with results lasting over a year for 73% of participants. More than 85% of patients reported satisfaction with their appearance post-treatment, and most adverse events were mild or moderate, resolving within 3 days. Already approved for cheek and chin augmentation, Juvéderm Voluma XC continues to expand its applications, offering innovative solutions for facial balance and contour.

March 19, 2024: FDA Approves Boehringer Ingelheim's Spesolimab-sbzo For Adults and Children With Generalized Pustular Psoriasis

The FDA expanded the approval of Boehringer Ingelheim's spesolimab-sbzo (Spevigo) injection to include treatment for generalized pustular psoriasis (GPP) in adults and adolescents aged 12 and older weighing at least 40 kg. This madeSpevigo the first targeted therapy to address both acute and chronic GPP needs.

The decision followed positive results from the 48-week Effisayil 2 trial, which showed an 84% reduction in GPP flare risk compared to placebo, with no flares observed in the high-dose group after the fourth week. Common adverse events included injection site reactions, urinary tract infections, and pruritus.

June 13, 2024: FDA Approves Tralokinumab Autoinjector for Adults With Moderate to Severe Atopic Dermatitis

The FDA has approved LEO Pharma's tralokinumab-ldrm (Adbry) single-use 300 mg autoinjector for adults with moderate to severe atopic dermatitis (AD). The device provides a more convenient option by halving the number of injections compared to the previously approved 1 mL pre-filled syringe.

Tralokinumab, approved in the US for patients aged 12 and older, is also available for adolescents and adults in several countries under different trade names. In Japan, Saudi Arabia, and Switzerland, it is approved exclusively for adults. Shannon Schneider, LEO Pharma’s senior medical affairs director, emphasized the importance of offering both the autoinjector and pre-filled syringe to meet diverse patient needs.

June 21, 2024: FDA Approves Sofpironium (Sofdra) as First and Only Chemical Entity for Primary Axillary Hyperhidrosis

The FDA approved Botanix Pharmaceutical's sofpironium (Sofdra) topical gel, 12.45%, for adults and children aged 9 and older with axillary hyperhidrosis, making it the first and only chemical entity approved for this condition.

Approval was based on phase 3 trial results showing 85% of patients experienced significant symptom improvement, with no serious treatment-related adverse events. Sofpironium, applied once daily with an applicator, had been available in Japan as Ecclock (5%) since 2020 through Botanix’s partner, Kaken Pharmaceutical.