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The epicutaneous immunotherapy for peanut allergy is continuing discussions with the FDA. What is its potential in allergic care?
The pathway toward US Food and Drug Administration (FDA)-regulated food allergy immunotherapy remains relatively new, ill-defined, and therefore, difficult to navigate during a time of growing evidence of benefit.
DBV Technologies, whose epicutaneous immunotherapy product Viaskin Peanut skin patch has been investigated for the treatment of pediatric peanut allergy, remains in close discussion with the FDA on matters of regulatory approval months after receiving a Complete Response Letter (CRL), and a couple years since first reporting phase 3 data evidencing the product’s benefit in peanut-allergic children aged 4-11 years old.
In the latest correspondence between the authority and the company, the FDA recommended the launch of a six-month, highly controlled safety and adhesion assessment of a modified Viaskin Patch in pediatric patients.
Collaboration toward FDA regulatory acceptance—which would make Viaskin only the second food immunotherapy marketed for prescribed use in the US—has become substantial enough to warrant a check-in on how the therapy may benefit prescribing allergists, as well as families inflicted by burdensome pediatric allergies.
In an interview with HCPLive®, DBV chief medical officer Pharis Mohideen, MD, MS, provided updates on the current work toward regulation for the immunotherapy. Mohideen also touched on the particular benefit Viaskin may provide severely at-risk patients, citing his own experiences in navigating allergies in his children.
“What we like to say is it’s like an airbag. Just because you have an airbag, you don’t go out and drive like a maniac,” Mohideen explained. “It’s that extra level of protection that you get.”