Privately held Leo Pharma Inc. has worked its way through a complete response letter issued in April to see the FDA approve Adbry (tralokinumab-ldrm) for treating moderate to severe atopic dermatitis in adults. The CRL noted FDA requests for additional data related to the device component, a prefilled syringe of tralokinumab, but it did not request new efficacy or safety data related to the drug product formulation. In April and on Dec. 28, the company did not provide details on the device-related data that were requested.
As more therapies are approved to treat severe atopic dermatitis, U.S. payers should make available at least one biologic and one JAK1 inhibitor, given how different the drug classes are in their onset of action and their risk profile, a panel of experts recommended at a recent Institute for Clinical and Economic Review (ICER) roundtable.
The FDA slapped Leo Pharma A/S’ BLA for IL-13 inhibitor tralokinumab with a complete response letter (CRL), making it the latest atopic dermatitis candidate to hit a regulatory setback in the U.S., following delays for three oral JAK inhibitor drugs earlier this month.
DUBLIN – The European Medicines Agency (EMA) has reiterated its support for Astrazeneca plc’s Vaxzervia COVID-19 vaccine, following an interim analysis of a data review, which the agency’s Committee on Human Medicinal Products (CHMP) has conducted over the past two weeks.
New articles highlighting phase III data on the IL-13 inhibitor tralokinumab from Leo Pharma A/S have shown that combining it with topical corticosteroids as needed was effective and well-tolerated in patients with moderate to severe atopic dermatitis.