DBV Soars As Path For Peanut Allergy Patch Approval Clears
Positive FDA Feedback After Earlier Rejection
The French biotech's chances of competing with Aimmune's Palforzia in the peanut allergy market have been boosted after US regulators decided that a fresh Phase III trial for the Viaskin Peanut patch would not be required for resubmission.
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Palforzia will almost certainly be the first treatment to get the green light for peanut allergy in Europe and its new owner will be hoping for a more successful launch than has been seen in the US.
Since Palforzia likely will be the only peanut allergy drug on market for some time, Nestle announces it will pay about $2.6bn to acquire the 80% of Aimmune it doesn’t own.
Aimmune has secured approval for the first ever peanut allergy treatment, but safety, cost and administration issues could limit the drug's uptake.