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The European Commission (EC) has approved Aimmune Therapeutics’ Palforzia, making it the first treatment for peanut allergy in the EU, according to the firm.
Aimmune has been granted a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its drug Palforzia as a treatment of peanut allergic patients aged 4-17 years.
Aimmune has announced the results from its Phase III European clinical trials for AR101, the company’s investigational oral biologic drug designed to help protect patients from severe allergic reactions in case they are accidentally exposed to peanut.
Aimmune has published the data from its phase III PALISADE clinical trial into AR101, a biologic immunotherapy indicated for desensitisation of patients with peanut allergies in the New England Journal of Medicine.