CHMP recommends approval of Adtralza in atopic dermatitis.- LEO Pharma
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AbbVie has announced The Lancet published primary analysis results from the pivotal global Phase III clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating Rinvoq (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic treatment.
LEO Pharma A/S, announced that the FDA as part of their review of the company’s Biologics License Application (BLA) for tralokinumab, an investigational therapy for adults with moderate-to-severe atopic dermatitis, has issued a Complete Response Letter requesting additional data relating to a device component of tralokinumab. FDA did not request any new data on the clinical efficacy or safety of the drug product formulation of tralokinumab.
LEO Pharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization of Adtralza (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.