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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