DB­V's peanut pre­ven­tion patch ap­proach­es key stage of ap­proval process

Al­most a year and a half af­ter DBV Tech­nolo­gies pulled its peanut al­ler­gy im­munother­a­py patch from FDA re­view, the biotech will get their day in court. The FDA has sched­uled an ad­vi­so­ry com­mit­tee hear­ing for May 15.

In the two-horse race to de­vel­op the first im­munother­a­py for peanut al­ler­gy, DBV had the ear­ly lead, fil­ing an NDA for their patch in 2018. But on De­cem­ber 20 of that year, the com­pa­ny with­drew their ap­pli­ca­tion af­ter, they said, meet­ing with reg­u­la­tors and de­ter­min­ing they had not sub­mit­ted “suf­fi­cient de­tail re­gard­ing da­ta on man­u­fac­tur­ing pro­ce­dures and qual­i­ty con­trols.” Aim­mune filed their BLA 3 days lat­er and won ap­proval as the first im­munother­a­py for peanuts this month.

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