Aim­mune wins 12-month re­view and ad­com for peanut al­ler­gy drug; Phase­Bio flies on ear­ly da­ta for Bril­in­ta re­ver­sal agent

→ Af­ter out­go­ing FDA com­mis­sion­er Scott Got­tlieb threw a span­ner in the works ear­li­er this year for peanut al­ler­gy drug de­vel­op­ers — Aim­mune $AIMT and DBV Tech­nolo­gies $DB­VT — sug­gest­ing in a se­ries of tweets that al­ler­genic prod­ucts are not cov­ered by user-fees, and con­se­quent­ly do not qual­i­fy for the PDU­FA process, Aim­mune on Mon­day of­fered some clar­i­ty re­gard­ing its mar­ket­ing ap­pli­ca­tion. The BLA for its prod­uct — AR101 — has been ac­cept­ed for re­view and will be mulled over by the FDA over 12 months. This pe­ri­od still keeps it ahead of arch ri­val DBV, which re­scind­ed its ap­pli­ca­tion last De­cem­ber — due to man­u­fac­tur­ing con­cerns — and plans to re­sub­mit in the third quar­ter. Aim­mune had sub­mit­ted its ap­pli­ca­tion to the FDA late last year — but the US gov­ern­ment shut­down stut­tered the reg­u­la­tor’s ac­cep­tance. “The FDA has in­formed Aim­mune that the BLA will be re­viewed…as mea­sured from the Jan­u­ary 2019 start date. As a con­se­quence, re­view of the BLA may take un­til late Jan­u­ary 2020. Aim­mune is cur­rent­ly en­gaged in dis­cus­sions with the FDA re­gard­ing the re­view time­line for the AR101 BLA. The FDA ex­pects to con­vene an ad­vi­so­ry com­mit­tee meet­ing to dis­cuss the ap­pli­ca­tion,” Aim­mune said in state­ment.

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