2024 Drug Approvals in Review: Part 2

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 2 of our comprehensive recap below, and keep an eye out for our coverage of what is to come in 2025.

July 2, 2024: FDA Approves RhodoLED XL Lamp Red Light Source for Use in Actinic Keratosis Treatment

Biofrontera Inc. announced that the FDA approved its RhodoLED XL lamp for treating mild to moderate actinic keratosis of the face and scalp, in combination with Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%. The RhodoLED XL lamp, featuring 5 illumination panels and positioning sensors, enhances photodynamic therapy by covering larger areas in a single session. This advancement aimed to improve ease of use for healthcare providers, offering better maneuverability for various patient positions. It builds on Biofrontera’sprevious model, the BF-RhodoLED.

July 9, 2024: FDA Approves Roflumilast Cream 0.15% For Atopic Dermatitis in Patients Aged 6 Years and Older

Arcutis Biotherapeutics announced that the FDA had approved its supplemental new drug application (sNDA) for roflumilast (Zoryve) cream 0.15% for treating mild to moderate atopic dermatitis in patients aged 6 and older. The approval was based on positive results from the INTEGUMENT clinical trials, which showed that roflumilast cream significantly improved symptoms compared to a vehicle. In both INTEGUMENT-1 and INTEGUMENT-2, patients treated with roflumilast achieved clear or almost clear skin, with a 40% improvement in the Investigator Global Assessment (vIGA-AD) score by week 4.

The cream’s approval was significant for pediatric patients, offering a non-steroidal option for those as young as 6 years old.

July 26, 2024: The FDA Approves Deuruxolitinib for Severe Alopecia in Adults

The FDA approved deuruxolitinib (Leqselvi; Sun Pharma), an oral Janus Kinase (JAK) inhibitor, for treating severe alopecia areata in adults. The approval was based on 2 phase 3 trials, which showed that one-third of patients treated with deuruxolitinib achieved at least 80% scalp hair coverage by week 24. Common adverse events included headache, acne, and nasopharyngitis, with rarer risks like infections and blood clots.

James Song, MD, highlighted the drug's fast-acting efficacy but noted safety concerns at higher doses, requiring more long-term data. The approval was welcomed by the medical community and the National Alopecia Areata Foundation, with Sun Pharma launching an access program to help eligible patients.

August 8, 2024: FDA Approves DenileukinDiftitox for Adults With Relapsed or Refractory Cutaneous T-Cell Lymphoma

The US Food and Drug Administration (FDA) approved Citius Pharmaceuticals' denileukindiftitox-cxdl (Lymphir) for adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL). Denileukindiftitox is the first treatment of its kind for CTCL, targeting the interleukin-2 (IL-2) receptor on malignant and regulatory T-cells. The approval was based on positive phase 3 data from a multi-center, open-label study that demonstrated its effectiveness for patients with recurrent or persistent CTCL stages I to III. In March 2023, the FDA accepted Citius’ Biologics License Application for denileukindiftitox after a resubmission in February 2023 following a Complete Response Letter in July 2023.

August 13, 2024: FDA Approves Nemolizumab for the Treatment of Prurigo Nodularis

Galderma announced that the US Food and Drug Administration (FDA) approved nemolizumab (Nemluvio) as a pre-filled pen for subcutaneous injection to treat adult patients with prurigo nodularis. The FDA had granted nemolizumab Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024. The approval was based on positive results from the phase 3 OLYMPIA clinical trials, the largest trial program for prurigo nodularis. Nemolizumab targets IL-31 cytokine signaling to address symptoms like chronic itch, skin nodules, and poor sleep. In the trials, significant reductions in itch intensity and improvements in skin nodule clearance and sleep disturbance were observed in patients treated with nemolizumab compared to placebo.

September 13, 2024: FDA Approves Lebrikizumab-lbkz for Moderate to Severe Atopic Dermatitis

The FDA approved Eli Lilly and Company's lebrikizumab-lbkz (Ebglyss) for children and adults aged 12 years and older with moderate to severe atopic dermatitis (AD). The IL-13 inhibitor is intended for patients whose AD was not controlled with topical therapies, with children needing to weigh at least 88 pounds. The approval was based on positive results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1,000 patients. At 16 weeks, 38% of patients using lebrikizumab achieved clear or almost clear skin, compared to 12% with placebo, and some saw results as early as 4 weeks. Most patients maintained improvements with monthly doses. For itch relief, 43% experienced relief by 16 weeks, with many sustaining it for up to a year.

September 23, 2024: FDA Approves UCB's Bimekizumab-bkzx for Psoriatic Arthritis

The FDA approved UCB's bimekizumab-bkzx (Bimzelx) for adults with active psoriatic arthritis (PsA) adding to its approvals for non-radiographic axial spondyloarthritis, ankylosing spondylitis, and plaque psoriasis. It is the first US-approved IL-17A and IL-17F inhibitor for these conditions.

In clinical trials, bimekizumab showed strong results, with 43-44% of PsA patients achieving ACR50 by week 16, compared to 7-10% with placebo. Among those with significant psoriasis, 69% achieved PASI90 versus 7% with placebo. Experts highlighted its consistent efficacy across patient groups and reassuring safety data.

October 14, 2024: FDA Approves 320 mg Bimekizumab Pre-Filled Syringe and Autoinjector

UCB announced FDA approval of 2 new delivery options for bimekizumab-bkzx (Bimzelx): a 2 mL pre-filled syringe and a pre-filled autoinjector, each containing a 320 mg dose. These devices cater to adults with moderate to severe plaque psoriasis and psoriatic arthritis, offering a single injection every 8 weeks for maintenance dosing.

The new options streamline treatment compared to the previous 1 mL, 160 mg injections, enhancing convenience and potentially improving patient adherence. Clinical trials confirmed the bioequivalence of the new 2 mL devices with the earlier regimen. 

November 4, 2024: FDA Approves Journey Medical’s DFD-29 for Rosacea

Journey Medical Corporation announced the FDA approval of minocycline hydrochloride 40 mg extended-release capsules (Emrosi) for treating erythema and inflammatory lesions in adult rosacea patients. Supported by phase 3 trials (MVOR-1 and MVOR-2), the drug demonstrated significant efficacy in reducing inflammatory lesions, erythema, and achieving treatment success with minimal adverse effects, the most common being dyspepsia. Emrosi, a best-in-class therapy, is the only oral systemic treatment approved for both erythema and inflammatory lesions in rosacea. Journey Medical plans to launch the drug by early 2025, aiming to establish it as a new standard of care.

November 20, 2024: FDA Approves Bimekizumab for Adults with Moderate to Severe HS

UCB announced the FDA approval of bimekizumab-bkzx (Bimzelx) for adults with moderate to severe hidradenitis suppurativa (HS), the first therapy to selectively inhibit IL-17A and IL-17F, addressing the inflammatory processes of this chronic skin condition. Supported by the phase 3 BE HEARD I and II trials, bimekizumab demonstrated significant efficacy, with patients achieving HiSCR50 and sustained HiSCR75 responses through 48 weeks. The therapy showed a favorable safety profile consistent with earlier studies. This marks the fifth FDA-approved indication for bimekizumab, highlighting UCB's commitment to addressing unmet needs in immune-mediated diseases and raising standards of care for HS patients.

December 13, 2024: ICYMI: FDA Approves Galderma's Nemolizumab for Moderate to Severe Atopic Dermatitis in Patients 12 and Older

Galderma announced that the US FDA approved nemolizumab (Nemluvio) for the treatment of moderate to severe atopic dermatitis (AD) in patients aged 12 years and older with a history of inadequate response to topical therapies. Nemolizumab is now indicated for combined use with topical corticosteroids and/or calcineurin inhibitors for this patient population.

December 16, 2024: FDA Approves Tapinarof Cream, 1% for Atopic Dermatitis in Patients 2 Years and Older

The US FDA announced that it approved tapinarof cream, 1% (Vtama; Organon) for patients aged 2 years and older with atopic dermatitis (AD). The approval is supported by positive data stemming from the phase 3 ADORING 1 and 2 studies, a pharmacokinetics trial in children, and interim results from the ongoing ADORING 3 trial.