Sanofi and Regeneron’s fully human monoclonal antibody Dupixent (dupilumab) has gained approval from the US Food and Drug Administration (FDA) for treating chronic spontaneous urticaria (CSU) in the adult and adolescent population aged 12 years and above.
This approval is specifically for those who continue to experience symptoms in spite of treatment with histamine-1 (H1) antihistamines.
The FDA’s decision is supported by data from the Phase III Study A and Study C clinical trials, which involved biologic-na茂ve subjects who are aged 12 years and above.
These subjects were symptomatic despite antihistamine use and were evaluated with the antibody Dupixent as an add-on treatment, against only antihistamine.
Both trials achieved their primary and key secondary endpoints, with the antibody showing minimisations in itch and urticaria severity at 24 weeks against a placebo.
Study B demonstrated further safety data and assessed the antibody in subjects over 12 who had no sufficient response or tolerance to anti-immunoglobulin E (IgE) therapy, while still symptomatic in spite of antihistamine use.
The safety outcomes from all three studies were in line with the antibody鈥檚 known safety profile in its approved indications.
Sanofi Immunology and Oncology Development Global Therapeutic Area head
Alyssa Johnsen said: 鈥淐SU patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living.
鈥淭his FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms.鈥�
The antibody has gained approval for this condition in the United Arab Emirates, Brazil and Japan, with submissions being reviewed in the European Union and other regulatory authorities globally.
CSU is stated to be a chronic inflammatory skin condition partly driven by type 2 inflammation, leading to recurring itch and severe hives.
Dupixent’s development programme claims to have demonstrated a decrease in type 2 inflammation in Phase III studies.
The antibody is being developed by the companies under a worldwide partnership agreement, and it was invented leveraging VelocImmune technology of Regeneron.
It has secured regulatory approvals in over 60 nations for various indications encompassing asthma, prurigo nodularis, chronic rhinosinusitis with nasal polyps, atopic dermatitis, chronic obstructive pulmonary disease, and eosinophilic esophagitis.
