Long jour­ney for DBV peanut patch ends in re­jec­tion by FDA

DBV Tech­nolo­gies’ long and wind­ing saga with the FDA has end­ed — for now, at least — with a CRL for their peanut al­ler­gy skin patch.

The re­jec­tion comes 21 months af­ter the com­pa­ny first filed for ap­proval. At the time, the French biotech was in a two-way race with Cal­i­for­nia’s Aim­mune to pro­duce the first FDA-ap­proved treat­ment for peanut al­ler­gy. But since then Aim­mune cleared that hur­dle, while DBV, af­ter a with­draw­al and re­sub­mis­sion, in­di­cat­ed that com­mu­ni­ca­tion be­tween them and reg­u­la­tors had bro­ken down.  In June, the com­pa­ny be­gan cut­ting pro­grams and em­ploy­ees.

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