GENE ONLINE|News &
Opinion
Blog

2022-06-08| Trials & Approvals

FDA OKs First Biologic for Children Under 5 With Moderate-to-Severe Atopic Dermatitis

by Joy Lin
Share To

Sanofi has announced the US FDA approval of Dupixent (dupilumab) as the first biologic medicine to treat children aged 6 months to 5 years with moderate-to-severe atopic dermatitis (eczema). The drug was previously FDA approved for children aged 6 to 11 years with the disease in 2020. 

A regulatory filing for the same age group is under review by the European Medicines Agency and submissions to regulatory authorities in other countries are underway. 

Related article: Cell and Gene Therapy Landscape in Japan is Moving Beyond Oncology

 

Clearer Skin and Reduced Itch 

 

“Moderate-to-severe atopic dermatitis in babies and young children is more than just a rash – the intense itch can make them scratch uncontrollably throughout the day and night and cause their skin to crack and bleed,” said Julie Black, President and CEO of the National Eczema Association. 

For many children, topical treatments do not adequately control the disease. In the US alone, more than 75,000 children under the age of 5 have uncontrolled moderate-to-severe disease, with most needing new treatment options. 

Dupixent is a fully-human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, which are thought to drive type 2 inflammation in atopic dermatitis. 

The latest FDA approval for the drug is based on results from a Phase 3 trial assessing Dupixent plus low-potency topical corticosteroids (TCS) or placebo (TCS alone). 

During the trial, Dupixent was administered every 4 weeks based on weight (200 mg for children ≥5 to <15 kg and 300 mg for children ≥15 to <30 kg). The trial met its primary endpoint, achieving an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area and Severity Index at week 16. 

All secondary endpoints were also met, which included clinically meaningful itch reduction at week 16. 

The long-term safety profile of Dupixent in children aged 6 months to 5 years through 52 weeks was also similar to the safety profile observed in the pivotal trial and consistent with what was observed in older patients with atopic dermatitis. 

Side effects include hand-foot-and-mouth disease and skin papilloma, reported in 5% and 2% of Dupixent patients aged 6 months to 5 years respectively. None of these cases led to treatment discontinuation.

Children who completed the trials were eligible to enroll in an open-label extension trial to assess the safety and efficacy of long-term treatment with Dupixent in this age group.

 

Blockbuster Drug in the Making

 

Dupixent is the result of a 15-year long collaboration between Sanofi and Regeneron. The drug began turning a profit for the drugmakers in 2019, fuelled by a clutch of approvals in prevalent diseases such as eczema, asthma and nasal polyps. 

In 2021, worldwide sales of Dupixent surpassed $5.6 billion (up 52.7% from the previous year), of which over $4.2 billion were generated in the US.

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
Walmart To Settle Opioid Lawsuits with $3.1 Billion, U.S. Government Mulls OTC Naloxone
2022-11-15
Sanofi, GSK Secure European COVID-19 Booster Approval, AstraZeneca Withdraws U.S. Application
2022-11-10
Insilico Makes its Biggest AI Deal Ever with Sanofi for Potential $1.2 Billion
2022-11-09
LATEST
Axsome’s AXS-05 Achieves Endpoints In Alzheimer’s Agitation Trial
2022-11-29
Spectrum to Cut 75% of Staff and NSCLC Program Following CLR
2022-11-28
Full-Life Technologies to Acquire Focus-X Therapeutics, Bolstering Peptide-Focused Radiopharmaceutical Pipeline
2022-11-28
Medeologix Acquires Three Silicon Valley Medical Device CDMO Companies and Establishes One-Stop Shop Mass Production Facilities in Taiwan
2022-11-28
GenFleet Therapeutics to Present Data from Phase I Trial of GFH009 Monotherapy at the 2022 Annual Meeting of American Society of Hematology (ASH)
2022-11-28
Everest’s Renal Drug Gets Placed On Fast Track For Approval In Taiwan And Korea
2022-11-28
Canada Authorizes Roche’s Polivy as First-Line Lymphoma Treatment
2022-11-27
EVENT
2022-12-01
BIOCHINA 2022
Online
2022-12-10
64TH ASH ANNUAL MEETING & EXPOSITION
New Orleans, USA
2022-12-14
BIOHK2022
Hong Kong, China
2023-01-07
7th Asia Microbiome Conference
Taipei, Taiwan
Scroll to Top

Create an account with us now to say goodbye to all the pop-ups!