FRANCE — The European Union’s medicines regulator has given a new stage of approval for Dupixent, Sanofi, and Regeneron’s product to treat children as young as 6 months old with severe atopic dermatitis.

The companies’ application was supported by 52-week data from a phase 3 trial consisting of three parts.

The European Commission is expected to announce a final decision on the Dupixent application in coming months.

Dupixent was approved in June 2022 by the U.S. Food and Drug Administration (FDA) regulator for children in this age group.

The use of Dupixent in infants and young children less than 6 years of age suffering from severe atopic dermatitis is at an investigational stage for now in the EU, pending final approval.

In October, Sanofi had forecast faster earnings growth due to strong demand for its bestselling drug Dupixent and for its flu vaccines.

Atopic dermatitis is a chronic type 2 inflammatory skin disease. Between 85% and 90% of patients first develop symptoms before the age of five, often continuing throughout adulthood.

Symptoms include intense, persistent itch and skin lesions covering much of the body and resulting in skin dryness and pain, which can increase the risk of skin infection.

Currently, treatment options in this age group are primarily topical corticosteroids (TCS), which the companies say can be associated with safety risks and may impair growth when used long term.

Dupixent, which is now approved to treat five diseases with underlying type 2 inflammation in the EU, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 and interleukin-13 pathways, shown to be central to type 2 inflammation.

Dupixent has continued its stellar performance on launches in pediatric atopic dermatitis, eosinophilic esophagitis, and prurigo nodularis.

The drug’s sales increased by 40% in the previous quarter. The trend is expected to continue in the upcoming quarter, as per Zacks, a leading investment research firm focusing on stock research, analysis, and recommendations.

The drug’s label expansion in recent months is likely to boost sales even further, which is projected to result in additional revenues for Regeneron and Sanofi.

Meanwhile, French drugmaker Sanofi is reviewing operations at two of its vaccine-making facilities in India and plans to let go of all employees at the plants, according to Reuters, after it failed to win a UNICEF contract.

The drugmaker is offering voluntary retirement scheme (VRS) to all its employees at two sites near Hyderabad, a spokesperson for Sanofi’s India unit told Reuters.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.