Regeneron Pharmaceuticals and Sanofi announced that the FDA has approved Dupixent for patients aged 12 to 17 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled by topical prescriptions or when those therapies are not advisable.
Dupixent (dupilumab) is a targeted biologic therapy that inhibits signaling of interleukin-4 and interleukin-13 — key proteins that may play a role in inflammation underlying atopic dermatitis (AD). The FDA approved dupilumab for the treatment of adults with moderate-to-severe AD in March 2017.
The new approval “will affect pediatricians a great deal,” Emma Guttman-Yassky, MD, PhD, vice chair in the department of dermatology and professor of dermatology at the Icahn School of Medicine at Mount Sinai, told Infectious Diseases in Children. “For children with moderate-to-severe disease, who have multiple areas of their body covered with eczema, we did not have any safe treatments until now. Once you exhausted the topical treatments — and in multiple areas of the body, you exhaust it quite fast — we didn’t have treatments that were sustainable.”
The FDA’s approval for adolescents was based on phase 3 trial results measuring dupilumab monotherapy in adolescents with uncontrolled moderate-to-severe AD. Researchers reported that safety and efficacy was generally consistent with what had been shown in adult studies. They said the average improvement in the Eczema Area and Severity Index from baseline was approximately 66% compared with 24% for the placebo group at 16 weeks of treatment, and that over seven times as many patients experienced significantly reduced itch with dupilumab treatment compared with placebo, according to a press release.
“Our hands really are tied when we treat these adolescents, and now we have a safe alternative that we can give them,” Guttman-Yassky said. “We did not have anything to give these children for long-term care control, and now this treatment opens such an option for us.”
Dupilumab is available in two doses — 200 mg and 300 mg — each as a prefilled syringe intended for subcutaneous injection to be administered either in the clinic or at home after training by a health care professional, according to the release.
“The bottom line is it is available, and it changes the game plan,” Guttman-Yassky said. “So, what is important for pediatricians is if you are comfortable, you can prescribe it, or you can refer out and a dermatologist will do it.”
Disclosure: Guttman-Yassky reports serving as a consultant for Regeneron and Sanofi.