Dupixent® (Dupilumab) — The World’s Most Broadly Approved Type 2 Inflammation Biologic

Six Approved Indications Across Dermatology, Respiratory Medicine, Gastroenterology and Allergy — All From a Single Twice-Monthly Injection

Dupixent® (Dupilumab) is a fully human IgG4 monoclonal antibody that simultaneously blocks the signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13) — the two master cytokines driving Type 2 inflammation — by binding with high affinity to the IL-4 receptor alpha (IL-4Rα) subunit shared by both the Type I (IL-4Rα/γc) and Type II (IL-4Rα/IL-13Rα1) receptor complexes. A single Dupixent injection simultaneously blocks both IL-4 and IL-13 signalling — comprehensively addressing the root inflammatory mechanism driving atopic dermatitis, severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic oesophagitis (EoE), prurigo nodularis, and COPD with type 2 inflammation.

Type 2 inflammation is now recognised as a systemic condition — the same underlying IL-4/IL-13-driven inflammatory biology drives manifestations across skin, airways, sinuses, gastrointestinal tract, and nerves. Dupixent uniquely addresses this systemic biology — a single biologic that simultaneously manages multiple co-existing Type 2 conditions that frequently affect the same patient — atopic dermatitis with asthma, asthma with CRSwNP, or all three together.

A.K. Pharma is a trusted medicine distributor in Delhi supplying genuine Dupixent (Dupilumab) in both 200mg and 300mg presentations to hospitals, dermatology centres, allergy clinics, respiratory medicine units, and pharmacies across India. Manufactured by Sanofi in partnership with Regeneron Pharmaceuticals, Dupixent is the fastest-growing biologic in pharmaceutical history — with annual revenues exceeding USD 14 billion in 2024 — reflecting its transformative clinical impact across conditions that were previously inadequately treated.

What is Dupixent (Dupilumab)?

Dupixent contains Dupilumab — a fully human IgG4 monoclonal antibody that targets the IL-4 receptor alpha subunit (IL-4Rα) — the shared component of two distinct receptor complexes:

Type I IL-4 Receptor (IL-4Rα/γc): Expressed on lymphocytes, mast cells, basophils, and dendritic cells. Mediates IL-4 signalling → drives Th2 cell differentiation, IgE class switching, and inflammatory cell activation.

Type II IL-4/IL-13 Receptor (IL-4Rα/IL-13Rα1): Expressed on keratinocytes, epithelial cells, smooth muscle, and fibroblasts. Mediates both IL-4 AND IL-13 signalling → drives tissue inflammation, barrier dysfunction, mucus production, airway remodelling, and fibrosis.

By binding IL-4Rα — the shared subunit — Dupilumab simultaneously blocks both receptor complexes with a single antibody molecule → comprehensive Type 2 pathway suppression from one injection.

Why Both IL-4 AND IL-13 Must Be Blocked: IL-4 and IL-13 have overlapping and complementary roles in Type 2 inflammation — blocking only IL-4 leaves IL-13-driven tissue effects intact; blocking only IL-13 leaves IL-4-driven lymphocyte activation intact. Dual IL-4/IL-13 blockade through IL-4Rα targeting provides more complete suppression than targeting either cytokine alone — which is why Dupilumab outperforms single-cytokine-targeting biologics in comparative analyses.

Full prescribing information is available at the FDA label for Dupilumab.

Clinical Studies and Evidence

SOLO 1 and SOLO 2 (Dupilumab Monotherapy — Moderate-Severe Atopic Dermatitis) Published in the New England Journal of Medicine (2016), these Phase 3 trials of 1,379 patients demonstrated at 16 weeks:

• IGA 0/1 (clear/almost clear skin) — 38% and 36% (Dupilumab) vs 10% and 8.5% (placebo)
• EASI-75 — 52% and 48% vs 15% and 12%
• PASI 100 (complete skin clearance) — demonstrated in long-term extensions
• Established Dupilumab as the first biologic to achieve clinically meaningful skin clearance in moderate-severe atopic dermatitis — transforming a condition that had no approved biologic for decades

CHRONOS Trial (52-Week Dupilumab + TCS in Atopic Dermatitis) Confirmed sustained year-long skin clearance with Dupilumab + topical corticosteroids — with no increase in serious adverse events over time — supporting long-term use with a consistent safety profile.

LIBERTY ASTHMA QUEST (Dupilumab in Uncontrolled Moderate-Severe Asthma) Published in the New England Journal of Medicine (2018) — 1,902 patients:

• Annualised severe exacerbation rate reduction — 47.7% overall; 65.8% in patients with eosinophils ≥300/µL
• Pre-bronchodilator FEV1 improvement — +0.32L vs +0.18L placebo
• Established Dupilumab for eosinophilic asthma — the broadest ARPU Type 2 biologic across skin and airways

LIBERTY ASTHMA VENTURE (OCS-Sparing) Dupilumab reduced oral corticosteroid dose by a median of 100% — with 48% of patients achieving complete OCS elimination — significantly superior OCS sparing vs placebo. Established Dupilumab as a critical OCS-sparing therapy reducing long-term steroid complications.

SINUS-24 and SINUS-52 (Dupilumab in CRSwNP) Significantly reduced nasal polyp size, nasal congestion, and SNOT-22 scores vs placebo — with significant restoration of sense of smell and reductions in need for sinus surgery or systemic corticosteroids.

TREET Trial (Dupilumab in Eosinophilic Oesophagitis) Published in the New England Journal of Medicine (2022) — Dupilumab 300mg weekly significantly improved dysphagia and histological outcomes (eosinophil count) vs placebo — the first approved biologic specifically for EoE.

PRIME and PRIME2 (Dupilumab in Prurigo Nodularis) Significantly reduced itch intensity and lesion counts — the first approved biologic for prurigo nodularis, a highly pruritic condition with no prior targeted treatment.

BOREAS and NOTUS (Dupilumab in COPD) Dupilumab significantly reduced moderate-severe COPD exacerbations in patients with type 2 eosinophilic inflammation (blood eosinophils ≥300/µL) — the first biologic approved for any form of COPD — a paradigm-shifting approval.

Available Strengths

Both strengths are available from A.K. Pharma.

Indications — What Dupixent is Used For

Atopic Dermatitis:

• Moderate-severe atopic dermatitis in adults and children ≥6 months inadequately controlled with topical therapies or where topical therapies are not advisable
• Used with or without topical corticosteroids

Moderate-Severe Asthma:

• Add-on maintenance for moderate-severe asthma in adults and children ≥6 years with eosinophilic phenotype or OCS-dependent asthma
• Reduces severe exacerbations, improves lung function, and eliminates OCS dependence

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP):

• Add-on maintenance in adults with inadequately controlled CRSwNP — with or without prior sinus surgery
• Reduces polyp size, improves nasal symptoms, smell, and prevents surgery

Eosinophilic Oesophagitis (EoE):

• Adults and children ≥1 year weighing ≥15kg
• First biologic approved specifically for EoE

Prurigo Nodularis:

• Adults with prurigo nodularis
• First approved biologic for this condition

COPD With Type 2 Inflammation:

• Adults with inadequately controlled COPD and elevated blood eosinophils (≥300/µL)
• First biologic approved for any form of COPD

For detailed indication information refer to MedlinePlus Dupilumab.

Key Benefits of Dupixent

Transforms Severe Atopic Dermatitis — Clear Skin Where Nothing Else Worked For patients who have lived with severe, treatment-refractory eczema for years — Dupixent achieves IGA 0/1 (clear or almost clear skin) in approximately 36-38% at 16 weeks of monotherapy, and significantly higher rates with TCS combination. The quality of life transformation — in sleep, mental health, social functioning, and daily life — is one of the most profound benefits of any biologic in dermatology.

Only Biologic Addressing All Manifestations of Type 2 Disease in One Patient Many patients have multiple co-existing Type 2 conditions — eczema + asthma + hay fever + nasal polyps. A single Dupixent injection addresses the shared biology driving all of these simultaneously. No other biologic offers this breadth of Type 2 disease coverage from one treatment.

Eliminating Oral Corticosteroid Dependency — Preventing Steroid Complications In OCS-dependent asthma, Dupilumab eliminates oral steroids completely in 48% of patients — dramatically reducing the devastating long-term consequences of chronic steroid use including osteoporosis, diabetes, adrenal suppression, cardiovascular disease, and cataracts. This OCS elimination benefit is one of the most clinically impactful aspects of Dupixent in severe asthma.

Paediatric Approval Down to 6 Months — Youngest Biologic Approval in Dermatology Approved for atopic dermatitis in infants from 6 months — addressing a significant unmet need in the youngest patients where chronic severe eczema causes profound suffering and disrupted sleep for both child and family.

First Biologic for COPD — Paradigm Shift The BOREAS/NOTUS approval is the first time any biologic has been approved for COPD — demonstrating that type 2 eosinophilic inflammation in COPD is a treatable endotype responsive to IL-4/IL-13 blockade. This challenges the view that COPD is purely structural and opens a new treatment pathway for patients with frequent exacerbations despite optimal inhaled therapy.

No Broad Immunosuppression — Favourable Long-Term Safety Dupixent selectively targets Type 2 inflammation without broadly suppressing the immune system — no increased risk of serious bacterial, viral, or opportunistic infections, no increased malignancy risk, and no organ toxicity. This safety profile supports long-term use including in paediatric patients.

Fastest-Growing Biologic in History — USD 14 Billion in 2024 Dupixent’s commercial success — the fastest biologic to reach and sustain peak revenues in pharmaceutical history — reflects its transformative clinical impact. This unprecedented adoption by dermatologists, allergists, pulmonologists, and gastroenterologists globally validates the clinical value across all six indications.

How Dupixent Works — IL-4/IL-13 Pathway in Type 2 Inflammation

The IL-23/Th17 Axis vs IL-4/IL-13 — Two Distinct Inflammatory Pathways: Type 2 inflammation is driven by a specific arm of the immune system — distinct from the IL-17-driven Type 3 inflammation (targeted by Scapho/Secukinumab and Copellor/Ixekizumab in psoriasis and spondyloarthritis). Understanding this distinction is key to appropriate biologic selection:

• Type 2 disease (Dupixent targets): Atopic dermatitis, asthma, CRSwNP, EoE, food allergy — driven by Th2 cells, ILC2s, IL-4, IL-13, IL-5, IL-31, IgE
• Type 3 disease (IL-17 biologics target): Psoriasis, psoriatic arthritis, ankylosing spondylitis — driven by Th17 cells, IL-17A, IL-23

Type 2 Inflammatory Cascade:

1. Epithelial barrier damage (skin, airway, gut) + allergen/irritant exposure → epithelial alarmins (TSLP, IL-25, IL-33) released
2. Alarmins activate ILC2s and dendritic cells → IL-4 and IL-13 produced
3. IL-4 → Th2 cell differentiation + IgE class switching in B cells → mast cell and basophil sensitisation
4. IL-13 → tissue-level effects: barrier dysfunction (skin), mucus hypersecretion (airways), smooth muscle hyperreactivity (asthma), oesophageal eosinophilic infiltration (EoE)
5. IL-5 → eosinophil recruitment and activation → eosinophilic inflammation in all affected tissues
6. IL-31 → itch neuron activation → pruritus in atopic dermatitis and prurigo nodularis

Dupilumab’s Mechanism:

Step 1 — IL-4Rα Binding: Dupilumab binds IL-4Rα with very high affinity — physically blocking both receptor complexes (Type I and Type II) from forming functional signalling units.

Step 2 — Dual Cytokine Pathway Blockade:

• IL-4 cannot signal through Type I complex → Th2 differentiation and IgE production reduced
• IL-4 and IL-13 cannot signal through Type II complex → tissue-level inflammation in skin, airways, sinuses, and oesophagus suppressed

Step 3 — Downstream JAK/STAT6 Suppression: Without IL-4/IL-13 receptor activation → no JAK1/TYK2 or JAK1/JAK2 → STAT6 is not phosphorylated → STAT6 target genes driving Type 2 inflammation are not transcribed → comprehensive Type 2 gene expression programme is suppressed.

Step 4 — Tissue-Specific Improvements:

• Skin: Keratinocyte barrier restoration, reduced eosinophil and T-cell infiltrate, reduced IL-31-driven itch → plaque clearance, reduced pruritus
• Airways: Reduced mucus, reduced eosinophilic infiltration, reduced smooth muscle hyperreactivity → improved FEV1, reduced exacerbations
• Sinuses: Reduced polyp-forming eosinophilic inflammation → polyp shrinkage, smell restoration
• Oesophagus: Reduced eosinophilic infiltration → histological remission, improved swallowing
• COPD: Reduced eosinophilic airway inflammation → reduced exacerbation frequency

For detailed mechanism overview refer to EAACI Atopic Dermatitis Guidelines and GINA Severe Asthma Treatment Guidelines.

Dupixent vs Nucala and Fasenra — Choosing the Right Biologic in Severe Asthma

Dosage and Administration

Atopic Dermatitis — Adults:

• Loading: 600mg SC (two 300mg injections simultaneously)
• Maintenance: 300mg SC every 2 weeks (Q2W)

Atopic Dermatitis — Paediatric (weight-based):

Moderate-Severe Asthma:

• Adults/≥12 years: 200mg or 300mg SC Q2W (no loading dose)
• Children 6–11 years: Weight-based dosing (100mg Q4W if <30kg; 200mg Q2W if ≥30kg)

CRSwNP:

• Adults: 300mg SC Q2W (no loading dose)

Eosinophilic Oesophagitis:

• Adults and children ≥1 year (≥15kg): 300mg SC weekly (more frequent than other indications)

Prurigo Nodularis:

• Adults: 600mg SC loading (two 300mg), then 300mg Q2W

COPD:

• Adults: 300mg SC Q2W

Administration:

• Subcutaneous — abdomen, thigh, or upper arm
• Allow syringe to reach room temperature — 45 minutes before injection
• Rotate injection sites — do not inject into areas that are tender, damaged, or bruised
• Patients may self-inject after training by healthcare professional

Full dosing guidelines available at Drugs.com Dupilumab Dosage.

Pre-Treatment Screening

Before starting Dupixent screen for:

• Helminth (parasitic) infections — treat before starting; Dupilumab may worsen inflammatory response to parasites
• Conjunctivitis risk — baseline ophthalmological assessment in patients with AD history of eye disease
• Active infections — do not initiate in patients with active serious infections

Who Should Use Dupixent

Atopic Dermatitis:

• Adults and children ≥6 months with moderate-severe AD failing topical therapies
• Patients who have failed or are intolerant to systemic immunosuppressants (cyclosporine, methotrexate, azathioprine)
• Patients where long-term broad immunosuppression is undesirable

Asthma:

• Adults and children ≥6 years with uncontrolled moderate-severe asthma and eosinophilic phenotype (eos ≥150/µL; greatest benefit ≥300/µL)
• OCS-dependent asthma patients — Dupixent is the preferred biologic for OCS elimination
• Patients with co-existing atopic dermatitis AND asthma — single biologic addresses both

CRSwNP:

• Adults with bilateral CRSwNP inadequately controlled on intranasal corticosteroids ± prior FESS
• Patients with AERD (aspirin-exacerbated respiratory disease) — Dupixent is particularly effective in this subset

EoE:

• Adults and children ≥1 year (≥15kg) with confirmed EoE — particularly suitable where dietary elimination and topical steroids have failed

COPD:

• Adults with inadequately controlled COPD and blood eosinophils ≥300/µL despite optimal inhaled therapy

Dupixent is prescribed by dermatologists, allergists/immunologists, respiratory physicians, gastroenterologists, and ENT surgeons. A.K. Pharma supplies Dupixent to hospitals, dermatology centres, allergy clinics, and pharmacies across Delhi and India.

Possible Side Effects

Common side effects include injection site reactions (pain, redness — 10-17%), conjunctivitis and keratitis (10-30% in atopic dermatitis — most clinically important side effect), nasopharyngitis, headache, and herpes simplex reactivation.

Conjunctivitis — Most Important Side Effect in Atopic Dermatitis: Conjunctivitis occurs in approximately 10-30% of adult AD patients on Dupixent — less common in asthma and CRSwNP. The mechanism is incompletely understood — possibly related to changes in ocular surface biology with Type 2 inflammation modulation. Management includes lubricating eye drops, topical antihistamines, and in persistent cases topical corticosteroid or cyclosporine eye drops. Ophthalmology review recommended for persistent or severe conjunctivitis. Dupixent is rarely discontinued for conjunctivitis — generally manageable.

Dupixent has a favourable serious adverse event profile — no increased risk of serious infections, malignancy, or major cardiovascular events demonstrated across clinical trials in over 10,000 patients.

Full side effect information available at FDA Dupilumab Safety Information.

Precautions

• Conjunctivitis — monitor eyes; lubricating drops for prophylaxis; ophthalmology for persistent cases
• Helminth infections — treat before starting; monitor and consider temporary discontinuation if infection develops during treatment
• Live vaccines — avoid concurrent administration
• Asthma patients — do not abruptly discontinue ICS or systemic steroids when starting Dupixent; taper gradually under physician supervision
• Eosinophilia — transient eosinophilia may occur in asthma patients; usually not clinically significant
• Pregnancy — limited data; use only if clearly needed; effective contraception recommended
• Refer to EAACI Atopic Dermatitis Guidelines and GINA Severe Asthma Guidelines for complete management context

Storage and Handling

• Store in refrigerator between 2°C and 8°C
• Do not freeze — discard if frozen
• Protect from light — keep in original carton
• Allow to reach room temperature before injection — 45 minutes
• Can be stored at room temperature below 25°C for up to 14 days — useful for travel
• Single use prefilled syringe — discard after use

As a responsible medicine distributor in Delhi, A.K. Pharma maintains full cold chain requirements during storage and supply of Dupixent ensuring product integrity.

Manufacturer Information

Dupixent (Dupilumab) is developed by Regeneron Pharmaceuticals and commercialised globally by Sanofi. Dupilumab received FDA approval in March 2017 for moderate-severe atopic dermatitis — with subsequent approvals for asthma (2018), CRSwNP (2019), paediatric AD extensions (2019-2022), EoE (2022), prurigo nodularis (2022), and COPD (2024). A.K. Pharma supplies only genuine Dupixent sourced from authorized distributors.

Related Allergy, Skin and Lung Medicines Available at A.K. Pharma

• Nucala (Mepolizumab) — anti-IL-5 for severe eosinophilic asthma, EGPA, and CRSwNP
• Fasenra (Benralizumab) — anti-IL-5Rα for severe eosinophilic asthma
• Scapho (Secukinumab) — anti-IL-17A for psoriasis and spondyloarthritis
• Copellor (Ixekizumab) — anti-IL-17A for psoriasis and spondyloarthritis
• Browse all Allergy Medicines available at A.K. Pharma

Frequently Asked Questions

Q. What is Dupixent used for? Dupixent (Dupilumab) treats moderate-severe atopic dermatitis, uncontrolled moderate-severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic oesophagitis, prurigo nodularis, and COPD with type 2 inflammation — six approved indications across four medical specialties from one biologic. More information at MedlinePlus.

Q. What is the generic name of Dupixent? Dupilumab. It is a fully human anti-IL-4Rα monoclonal antibody that simultaneously blocks IL-4 and IL-13 signalling — developed by Regeneron and commercialised by Sanofi.

Q. How does Dupixent work for atopic dermatitis? In atopic dermatitis, IL-4 and IL-13 drive barrier dysfunction, inflammation, and itch by activating keratinocytes, immune cells, and itch nerve fibres. Dupilumab blocks IL-4Rα — the shared receptor component for both cytokines — simultaneously suppressing both inflammatory pathways at the tissue level. This addresses the root cause rather than just managing surface symptoms.

Q. Why does Dupixent treat so many different conditions? Because atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis, and COPD with type 2 inflammation all share the same underlying biological mechanism — IL-4 and IL-13 driven Type 2 inflammation. Dupixent’s mechanism targets this shared biology — one treatment for all Type 2 manifestations.

Q. How quickly does Dupixent work? In atopic dermatitis, itch improvement is often noticed within the first 2 weeks. Significant skin clearance is visible by weeks 4-8 with maximum response typically by weeks 16-24. In asthma, exacerbation reduction and FEV1 improvement typically occur within the first 4-8 weeks.

Q. What is conjunctivitis with Dupixent and how is it managed? Conjunctivitis (eye redness and irritation) occurs in approximately 10-30% of atopic dermatitis patients — less common in other indications. Usually mild-to-moderate and managed with lubricating eye drops. Persistent cases should be reviewed by an ophthalmologist. It is rarely severe enough to require treatment discontinuation.

Q. Can Dupixent be used in children as young as 6 months? Yes — Dupixent is approved for atopic dermatitis in infants from 6 months — the youngest approved biologic in dermatology. Weight-based dosing applies for paediatric patients. It is also approved for asthma from age 6 years and EoE from age 1 year.

Q. Does Dupixent need refrigeration? Yes — store between 2°C and 8°C. Can be stored at room temperature below 25°C for up to 14 days for travel. Do not freeze.

Q. Is Dupixent available in India? Dupixent can be supplied to hospitals, dermatology centres, allergy clinics, and pharmacies across India. Contact A.K. Pharma — medicine distributor in Delhi — for availability and pricing.

Q. What is the price of Dupixent in India? Price varies by strength and pack. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.

Q. How to order Dupixent from A.K. Pharma? Request a quote from this page, call 011 4172 6999, or WhatsApp +91 9810034827 with your requirements.

Q. Does A.K. Pharma supply Dupixent in bulk? Yes — in bulk to dermatology centres, allergy clinics, hospitals, and pharmacies across Delhi and India. Contact us for bulk pricing.

Why Order Dupixent from A.K. Pharma?

• Licensed medicine distributor in Delhi with all required drug licenses
• 100% genuine Dupixent sourced from authorized Sanofi/Regeneron distributors
• Cold chain maintained throughout storage and delivery
• Both 200mg and 300mg presentations available
• Available alongside companion Type 2 inflammation biologics — Nucala, Fasenra — simplifying allergy/immunology procurement
• Bulk supply available for hospitals and dermatology centres
• Prompt response to all quote requests
• Serving dermatologists, allergists, and respiratory physicians across Delhi NCR and India

Contact A.K. Pharma for Dupixent Supply 📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052 📞 011 4172 6999 📱 WhatsApp: +91 9810034827 🌐 akpharma.in