Press Release: Dupixent late-breaking positive pivotal data in bullous pemphigoid presented at AAD

Dupixent late-breaking positive pivotal data in bullous pemphigoid presented at AAD

• 5 instances extra adults on Dupixent achieved sustained illness remission at 36 weeks in comparison with placebo; important reductions had been additionally seen in illness severity and itch
• Dupixent additionally considerably lowered oral corticosteroid and rescue medication use in comparison with placebo

• Data help the potential of Dupixent to be the primary and solely focused medication to deal with bullous pemphigoid, a pores and skin illness with underlying kind 2 irritation; regulatory submissions are beneath evaluation in the US and the EU

Paris and Tarrytown, NY, March 8, 2025. Positive outcomes from the pivotal ADEPT section 2/3 examine evaluating the investigational use of Dupixent (dupilumab) in adults with moderate-to-severe bullous pemphigoid (BP) had been shared in a late-breaking oral presentation at the 2025 American Academy of Dermatology (AAD) Annual Assembly. BP is a continual, debilitating, and relapsing pores and skin illness with underlying kind 2 irritation and characterised by intense itch and blisters, reddening of the pores and skin, and painful lesions.

Victoria Werth, MD
Chief of the Division of Dermatology at the Philadelphia Veterans Administration Hospital, Professor of Dermatology and Drugs at the Hospital of the College of Pennsylvania and the Veteran’s Administration Medical Heart, and principal investigator of the examine
“Individuals with bullous pemphigoid reside with unrelenting itch, blisters, and painful lesions that may be debilitating and make it tough to operate each day. Furthermore, present therapy choices could be difficult for this primarily aged affected person inhabitants as a result of they work by suppressing their immune system. By concentrating on the underlying kind 2 irritation, which is a key driver for bullous pemphigoid, Dupixent is the primary investigational biologic to point out sustained illness remission and cut back illness severity and itch in comparison with placebo in a scientific examine.”

The ADEPT examine met all main and key secondary endpoints, enrolling 106 adults with moderate-to-severe BP who had been randomized to obtain Dupixent 300 mg (n=53) each two weeks after an preliminary loading dose or placebo (n=53) added to standard-of-care oral corticosteroids (OCS). Throughout therapy, all sufferers underwent a protocol-defined OCS tapering routine if management of illness exercise was maintained. Sustained illness remission was outlined as full scientific remission with completion of OCS taper by week 16 with out relapse and no rescue remedy use throughout the 36-week therapy interval.

As presented at AAD, outcomes for Dupixent-treated sufferers at 36 weeks, in comparison with these handled with placebo, had been as follows:

• 20% skilled sustained illness remission, the first endpoint, in comparison with 4% (p=0.0114)
• 40% achieved ≥90% discount in illness severity in comparison with 10% (p=0.0003)
• 40% achieved clinically significant itch discount in comparison with 11% (p=0.0006)
• 1678 mg discount in cumulative OCS publicity (p=0.0220) on common and a 54% decrease threat of rescue treatment use (p=0.0016)

On this aged inhabitants, total charges of hostile occasions (AEs) had been 96% (n=51) for Dupixent and 96% (n=51) for placebo. AEs extra generally noticed with Dupixent in comparison with placebo in at least 3 sufferers included peripheral edema (n=8 vs. n=5), arthralgia (n=5 vs. n=3), again ache (n=4 vs. n=2), blurred imaginative and prescient (n=4 vs. n=0), hypertension (n=4 vs. n=3), bronchial asthma (n=4 vs. n=1), conjunctivitis (n=4 vs. n=0), constipation (n=4 vs. n=1), higher respiratory tract an infection (n=3 vs. n=1), limb damage (n=3 vs. n=2), and insomnia (n=3 vs. n=2). There have been no AEs resulting in loss of life in the Dupixent group and a couple of AEs resulting in loss of life in the placebo group.

In February, the US Meals and Drug Administration (FDA) accepted for precedence evaluation the supplemental biologics license utility for Dupixent to deal with BP. The FDA determination is predicted by June 20,2025. Dupixent was beforehand granted orphan drug designation by the FDA for BP, which applies to investigational medicines meant for the therapy of uncommon ailments that have an effect on fewer than 200,000 folks in the US. Further purposes are additionally beneath evaluation world wide, together with in the EU.

The protection and efficacy of Dupixent in BP are at the moment beneath scientific investigation and haven’t been evaluated by any regulatory authority.

About BP
BP is a continual, debilitating, and relapsing pores and skin illness with underlying kind 2 irritation that sometimes happens in an aged inhabitants. It’s characterised by intense itch and blisters, reddening of the pores and skin, and painful lesions. The blisters and rash can kind over a lot of the physique and trigger the pores and skin to bleed and crust, ensuing in sufferers being extra susceptible to an infection and affecting their each day functioning. Roughly 27,000 adults in the US reside with BP that’s uncontrolled by systemic corticosteroids.

Concerning the Dupixent BP pivotal examine
ADEPT is a randomized, section 2/3, double-blind, placebo-controlled examine evaluating the efficacy and security of Dupixent in 106 adults with moderate-to-severe BP for a 52-week therapy interval. After randomization, sufferers acquired Dupixent or placebo each two weeks, with OCS therapy. Throughout therapy, OCS taper was initiated after sufferers skilled two weeks of sustained management of illness exercise. OCS tapering might begin between 4 to 6 weeks after randomization and was continued so long as illness management was maintained, with the intent of completion by 16 weeks. After OCS tapering, sufferers had been solely handled with Dupixent or placebo for at least 20 weeks, except rescue therapy was required.

The first endpoint evaluated the proportion of sufferers attaining sustained illness remission at 36 weeks. Sustained illness remission was outlined as full scientific remission with completion of OCS taper by 16 weeks with out relapse and no rescue remedy use throughout the 36-week therapy interval. Relapse was outlined as look of ≥3 new lesions a month or ≥1 giant lesion or urticarial plaque (>10 cm in diameter) that didn’t heal inside per week. Rescue remedy might embrace therapy with high-potency topical corticosteroids, OCS (together with enhance of OCS dose throughout the taper or re-initiation of OCS after completion of the OCS taper), systemic non-steroidal immunosuppressive medicines, or immunomodulating biologics.

Choose secondary endpoints evaluated at 36 weeks included:

• Proportion of sufferers attaining ≥90% discount in Bullous Pemphigoid Illness Space Index (scale: 0-360)
• Proportion of sufferers with ≥4-point discount in Peak Pruritus Numerical Score Scale (scale 0-10) rating
• Whole cumulative OCS dose
• Time to first use of rescue treatment

About Dupixent
Dupixent (dupilumab) is a totally human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways and isn’t an immunosuppressant. The Dupixent growth program has proven important scientific profit and a lower in kind 2 irritation in section 3 research, establishing that IL4 and IL13 are two of the important thing and central drivers of the kind 2 irritation that performs a serious position in a number of associated and infrequently co-morbid ailments.

Dupixent has acquired regulatory approvals in greater than 60 nations in a number of indications together with sure sufferers with atopic dermatitis, bronchial asthma, continual rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, continual spontaneous urticaria, and continual obstructive pulmonary illness in completely different age populations. Multiple million sufferers are being handled with Dupixent globally.

Dupilumab growth program
Dupilumab is being collectively developed by Sanofi and Regeneron beneath a world collaboration settlement. So far, dupilumab has been studied throughout greater than 60 scientific research involving greater than 10,000 sufferers with numerous continual ailments pushed in half by kind 2 irritation.

Along with the at the moment permitted indications, Sanofi and Regeneron are finding out dupilumab in a broad vary of ailments pushed by kind 2 irritation or different allergic processes in section 3 research, together with continual pruritus of unknown origin, bullous pemphigoid, and lichen simplex chronicus. These potential makes use of of dupilumab are at the moment beneath scientific investigation, and the security and efficacy in these circumstances haven’t been totally evaluated by any regulatory authority.

About Regeneron
Regeneron (NASDAQ: REGN) is a number one biotechnology firm that invents, develops and commercializes life-transforming medicines for folks with critical ailments. Based and led by physician-scientists, our distinctive skill to repeatedly and constantly translate science into medication has led to quite a few permitted remedies and product candidates in growth, most of which had been homegrown in our laboratories. Our medicines and pipeline are designed to assist sufferers with eye ailments, allergic and inflammatory ailments, most cancers, cardiovascular and metabolic ailments, neurological ailments, hematologic circumstances, infectious ailments, and uncommon ailments.

Regeneron pushes the boundaries of scientific discovery and accelerates drug growth utilizing our proprietary applied sciences, similar to VelociSuite^®, which produces optimized totally human antibodies and new courses of bispecific antibodies. We’re shaping the following frontier of medication with data-powered insights from the Regeneron Genetics Heart^® and pioneering genetic medication platforms, enabling us to establish revolutionary targets and complementary approaches to doubtlessly deal with or treatment ailments.

For extra data, please go to www.Regeneron.com or observe Regeneron on LinkedIn, Instagram, Fb or X.

About Sanofi
We’re an revolutionary world healthcare firm, pushed by one objective: we chase the miracles of science to enhance folks’s lives. Our group, internationally, is devoted to remodeling the observe of medication by working to show the inconceivable into the doable. We offer doubtlessly life-changing therapy choices and life-saving vaccine safety to tens of millions of individuals globally, whereas placing sustainability and social duty at the middle of our ambitions.

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