Aim­mune's peanut al­ler­gy im­munother­a­py clears Eu­ro­pean PhI­II with fly­ing col­ors, paving way for first US, EU ther­a­peu­tic ap­proval

Days af­ter the FDA fi­nal­ly ac­cept­ed the ap­pli­ca­tion to re­view its peanut al­ler­gy im­munother­a­py, Aim­mune laid out pos­i­tive piv­otal study da­ta from its Eu­ro­pean Phase III study on Mon­day, paving the way for an EMA mar­ket­ing ap­pli­ca­tion by mid-2019.

The drug de­vel­op­er, which has es­sen­tial­ly leapfrogged its arch ri­val DBV Tech­nolo­gies $DB­VT in the Unit­ed States, said its drug — AR101 — helped shore up tol­er­ance in peanut-al­ler­gic sub­jects in a 175-pa­tient tri­al called ARTEMIS. Pa­tients un­der­went ap­prox­i­mate­ly six months of dose es­ca­la­tion and then three months at a dai­ly ther­a­peu­tic dose of AR101 at 300 mg or place­bo, fol­lowed by a place­bo-con­trolled food chal­lenge.

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