The European Commission (EC) has approved Aimmune Therapeutics’ Palforzia, making it the first treatment for peanut allergy in the EU, according to the firm. Following the EC approval, Palforzia will be available to patients aged four to 17 years with a confirmed diagnosis of peanut allergy. It is not, however, indicated for the treatment of allergic reactions – including anaphylaxis – and must be used in conjunction with a peanut-avoidant diet. The drug can also be continued in patients aged 18 years or older, Aimmune added in a statement. The EC approval was based on a data package including two phase III clinical trials – PALISADE and ARTEMIS. Across both studies, Palforzia treatment led to a significant increase in the amount of peanut protein tolerated in participants with peanut allergy, compared to placebo. “Today’s approval is a historic moment for the millions of people living with potentially life-threatening peanut allergy, ...
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