⚡First FDA-Approved Biologic for BP

Good morning — it’s Saturday, June 28, and we’re covering dupilumab’s approval as the first targeted therapy for bullous pemphigoid, new 100-week data on Nemluvio in prurigo nodularis, and more.

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The FDA has approved Sanofi and Regeneron’s dupilumab (Dupixent) as the first targeted biologic for bullous pemphigoid.

The approval was based on the ADEPT Phase 2/3 trial, in which investigators randomized 106 adults with moderate-to-severe bullous pemphigoid to receive dupilumab or placebo in combination with standard-of-care oral corticosteroids. Oral corticosteroids were tapered over 16 weeks if disease control was maintained.

At Week 36, 18% of patients on dupilumab achieved sustained remission, versus 6% on placebo. Sustained remission was defined as complete clinical remission and successful corticosteroid taper by Week 16, with no relapse and no use of rescue therapies.

Clinically meaningful itch reduction (≥4-point PP-NRS improvement; range 0–10) occurred in 38% of dupilumab-treated patients, compared to 11% on placebo. Median cumulative oral corticosteroid doses were also notably lower (2.8 grams vs. 4.1 grams).

The most common adverse events (≥2%) reported with dupilumab were arthralgia, conjunctivitis, blurred vision, herpes infections, and keratitis.

Dupilumab is now approved for eight diseases driven by type 2 inflammation, from common conditions like asthma and atopic dermatitis to rarer ones like eosinophilic esophagitis, prurigo nodularis, and now bullous pemphigoid. More than one million patients have been treated globally.

> Nemluvio maintains long-term response in prurigo nodularis at 100 weeks: Galderma presented late-breaking data from the OLYMPIA long-term extension trial at the 2025 International Congress of Dermatology, showing sustained improvements through two years with nemolizumab (Nemluvio) in moderate-to-severe prurigo nodularis. Among 508 patients who continued from earlier trials and were followed to Week 100, at least 80% achieved 76–100% healed pruriginous lesions, and approximately 75% attained clearance or almost-clearance of all nodules (IGA 0/1). Over 70% were itch-free or nearly itch-free. The long-term safety profile remained favorable. These results build on favorable two-year data from the ARCADIA long-term extension study in atopic dermatitis presented earlier this month. The IL-31RA inhibitor is now approved in the U.S., EU, and other markets for both prurigo nodularis and atopic dermatitis.

> Stem cell reactivator PP405 shows early hair density gains in Phase 2a trial: Pelage Pharmaceuticals announced positive Phase 2a results for PP405, a first-in-class topical regenerative therapy for androgenetic alopecia. PP405 reactivates dormant hair follicle stem cells—targeting the core biological mechanism of follicle cycling rather than secondary hormonal pathways. In the 78-patient randomized trial, participants applied PP405 or placebo daily for four weeks and were followed through Week 12. The trial met its primary safety and pharmacokinetic endpoints, with no systemic absorption detected. By Week 8, 31% of treated men with advanced hair loss achieved a >20% increase in hair density, compared to 0% in the placebo group. Unlike existing treatments, which primarily maintain hair from active follicles, PP405 also induced new growth in previously hairless follicles, underscoring its regenerative potential. The early response is notable, given that current treatments often require 6 to 12 months for visible regrowth. Pelage expects to initiate Phase 3 trials in 2026. The company is backed by a premier investor syndicate led by Google Ventures.

> Deucravacitinib shows durable joint and skin responses in psoriatic arthritis trial: At EULAR 2025, Bristol Myers Squibb presented late-breaking results from the Phase 3 POETYK PsA-1 trial showing that deucravacitinib (Sotyktu) significantly improved joint and skin outcomes in adults with psoriatic arthritis. The study enrolled 670 patients with active disease and no prior biologic treatment. At Week 16, 54% of those on deucravacitinib achieved an ACR20 response—defined as a ≥20% improvement in joint counts and in at least three of five additional domains—compared to 34% on placebo (P < 0.0001). Skin clearance was also notable, with 52% achieving at least a 75% reduction in skin severity (PASI 75), versus 7% on placebo. The once-daily oral TYK2 inhibitor was well tolerated, with a safety profile consistent with prior psoriasis trials. Investigators also presented data from the companion POETYK PsA-2 trial, which included patients who were either biologic-naïve or previously treated with a TNF inhibitor. At Week 52, 62% of those who started and remained on deucravacitinib achieved ACR20, reinforcing the therapy’s durability.

> Briquilimab achieves rapid deep control in cold urticaria and dermographism: Jasper Therapeutics reported that, at the 180mg dose, briquilimab led to complete response in 11 of 12 patients (92%) with antihistamine-refractory chronic inducible urticaria (CIndU) during the course of the 8-week analysis period. The subcutaneous monoclonal antibody targets the KIT receptor, depleting mast cells by blocking stem cell factor signaling. The open-label Phase 1b/2a trial enrolled 27 adults with symptomatic dermographism or cold urticaria—two major CIndU subtypes—with 12 receiving the 180mg dose. All 12 patients (100%) achieved a clinical response within 8 weeks, and 66% responded by Week 2. At Week 8, 7 patients (58%) maintained their response, including 5 with complete and 2 with partial responses. Tryptase levels fell below the lower limit of quantification in 83% of patients. No serious or grade ≥3 adverse events occurred, and there were no reports of hair or skin color changes. Half experienced transient, mild neutropenia. Briquilimab is also being studied in chronic spontaneous urticaria and asthma.

> Dupilumab may raise psoriasis risk in atopic dermatitis but the absolute difference remains low: A large, propensity-matched study of 19,720 patients with atopic dermatitis found that dupilumab increased psoriasis risk, although the small absolute difference suggests limited clinical relevance. Dupilumab users had a 58% higher risk of psoriasis compared to those prescribed other systemic agents such as methotrexate or cyclosporine (HR 1.58; 95% CI, 1.25–1.99). Over three years, cumulative incidence was 2.86% with dupilumab versus 1.79% with other systemic therapies. This corresponds to a number needed to harm of 94—suggesting modest clinical relevance. Psoriatic arthritis was also slightly more common in the dupilumab group, though the difference was not statistically significant (HR 1.97; 95% CI, 0.75–5.18). Limitations include the observational design, potential residual confounding, lack of atopic dermatitis severity data, and possible misclassification of outcomes. Mechanistically, IL-4 blockade with dupilumab may shift immune responses toward Th17-driven inflammation, potentially triggering psoriatic disease.

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