FDA issues Complete Response Letter for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis.- Leo Pharma.
“We are committed to bringing tralokinumab to the market to support the millions of U.S. adults who live with uncontrolled moderate-to-severe atopic dermatitis. The FDA has not raised any questions to the clinical efficacy or safety of tralokinumab, but only requested additional data relating to a device component of the combination product. We will now work closely with the FDA to address their request and bring tralokinumab to the U.S. patients as quickly as possible.” said Jörg Möller, Executive Vice President, Global Research and Development at LEO Pharma. The BLA submission was based on efficacy and safety results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase III trials, which included more than 1,900 adult patients with moderate-to-severe atopic dermatitis. Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose-finding trial, and a vaccine response trial. LEO Pharma received a positive opinion for tralokinumab from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on April 22, 2021.
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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.