DUPIXENT

批准信原文要点

This Changes Being Effected sBLA provides for the addition of the statement “Per Pre-filled Syringe,” or “Per Pre-filled Pen,” to the dose bar of the pre-filled syringe and pre-filled pen cartons, respectively, in response to Agency labeling comments dated June 6, 2025.

批准信原文要点

This Prior Approval sBLA provides for expanding the indication for chronic spontaneous urticaria (CSU) to include pediatric patients aged 2 years to less than 12 years.

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We also refer to our letter dated March 4, 2026, notifying you under Section 505(o)(4) of the FDCA, of new safety information ... ocular infections, irritations, and inflammation. This sBLA provides for revisions to the labeling for Dupixent that are consistent with our March 4, 2026, letter.

批准信原文要点

This Prior Approval sBLA provides for a new indication of treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery.

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This Prior Approval supplemental biologics license application provides for use of Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP).

批准信原文要点

This corrected action letter incorporates the corrections of the errors. The effective action date will remain April 17, 2025, the date of the original letter. This Prior Approval supplemental biologics license application provides for use of Dupixent for the treatment of adult and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.

批准信原文要点

We also refer to our letter dated January 24, 2025, notifying you, under Section 505(o)(4) of the FDCA, of new safety information ... risk of new onset psoriasis, psoriatic arthritis, and vasculitis.

批准信原文要点

This Prior Approval supplemental biologics license application provides for the use of Dupixent as an add-on maintenance treatment in adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

批准信原文要点

This Prior Approval supplemental biologics license application provides for the use of Dupixent as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

批准信原文要点

This “Changes Being Effected” supplemental biologics application provides for removal of the Dupixent 100 mg dosage form.

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This Prior Approval supplemental biologics license application provides for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis.

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This Prior Approval supplemental biologics license application updates the clinical studies section of the USPI with the results from a clinical trial in atopic dermatitis with hand and/or foot involvement.

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This Prior Approval supplemental biologics application provides for the labeling update to include long-term safety data of Dupixent use in the treatment of adults with atopic dermatitis.

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This “Changes Being Effected” supplemental biologics application provides for updates to the Instructions for Use in response to an Agency supplement request letter dated October 28, 2022.

批准信原文要点

We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text.

批准信原文要点

This Prior Approval supplemental biologics license application provides for a new indication – for the treatment of adult patients with prurigo nodularis (PN).

批准信原文要点

This Prior Approval supplemental biologics license application provides for an extension of the age range for the atopic dermatitis indication to allow for the “treatment of patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.”

批准信原文要点

This Prior Approval supplemental biologics license application provides for the treatment of adult and pediatric patients ages 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis.

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S-033: Addition of facial skin reactions to the postmarketing adverse reactions section.

批准信原文要点

The Prior Approval supplemental biologics applications provide for… • S-021: Addition of angioedema… • S-027: Addition of information related to the conjunctivitis and keratitis… The “Changes Being Effected”… • S-033: Addition of facial skin reactions…

批准信原文要点

The Prior Approval supplemental biologics applications provide for… • S-021: Addition of angioedema… • S-027:… conjunctivitis and keratitis… The “Changes Being Effected”… • S-033: Addition of facial skin reactions…

批准信原文要点

This Prior Approval supplemental biologics application provides for the use of dupilumab as an add-on maintenance treatment of patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.

批准信原文要点

This Prior Approval supplemental biologics application provides for updates to the labeling to include long-term safety data for DUPIXENT in adult patients with atopic dermatitis.

批准信原文要点

This Prior Approval supplemental biologics application provides for a new presentation: 200 mg (175 mg/mL) auto-injector (pre-filled pen).

批准信原文要点

Changes Being Effected supplemental biologics application S-015 provides for updating the label with information… pregnancy exposure registry. Prior Approval supplemental biologics application S-017 provides for a new 300 mg (150 mg/mL) pre-filled pen presentation.

批准信原文要点

Changes Being Effected supplemental biologics application S-015 provides for updating the label with information for patients and prescribers about an enrolling pregnancy exposure registry. Prior Approval supplemental biologics application S-017 provides for a new 300 mg (150 mg/mL) pre-filled pen presentation.

批准信原文要点

This Prior Approval supplemental biologics application… provides for a new patient population: patients with moderate-to-severe atopic dermatitis (AD) aged ≥ 6 to < 12 years.

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This Prior Approval supplemental biologics application provides for the use of dupilumab as add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis.

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This Prior Approval supplemental biologics application proposes a new patient population: patients 12 to less than18 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

批准信原文要点

This Prior Approval supplemental biologics application provides for the use of dupilumab for the add-on maintenance treatment in patients with moderate to severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma.

批准信原文要点

Update the Prescribing Information to include the results of drug-drug interaction study R668-AD-1433. • Update the Prescribing Information to include the results for study R668-AD-1415, titled “A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigation the Efficacy and Safety of Multiple Dupilumab Dose Regimens Administered as Monotherapy for Maintaining Treatment Response in Patients with Atopic Dermatitis.”

批准信原文要点

This “Changes Being Effected” supplemental biologics application provides for updates to the Important Information section of the Instructions for Use (IFU).