The FDA approves remibrutinib for symptomatic dermographism, the first such therapy, extending an oral BTK inhibitor label via the Phase III RemIND trial.
News|Articles|June 12, 2020
EMA Validates MAA for Leo Pharma’s Tralokinumab
Author(s)Pharmaceutical Technology Editors
Leo Pharma, medical dermatology specialist, has announced that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for tralokinumab.
Advertisement
Leo Pharma, medical dermatology specialist, has announced, in a June 11, 2020 press release, that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for tralokinumab.
Tralokinumab is an investigational, fully human, immunoglobin G4 monoclonal antibody for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD). EMA’s decision to validate the MAA for tralokinumab has been based on data from ECZTRA 1,2, and 3 Phase III studies, which evaluated the efficacy and safety of the treatment as monotherapy.
“People living with atopic dermatitis often face tremendous physical, social, and emotional challenges,” said Kim Kjøller, executive vice-president, Global Research and Development, LEO Pharma, in the press release. “Since atopic dermatitis is a heterogeneous disease, we are focused on targeted therapies with the potential to treat individual needs and reduce this burden. We look forward to working closely with EMA as they review this application.”
Source:
Advertisement
Related to this article
The company is showcasing new development solutions and advanced digital technologies including its new OSD Express and Steriles Express solutions for drug development.
Ron Scarboro, Azurity Pharmaceuticals, explains when formulation robustness justifies added cost and which post-approval quality and supply metrics teams can track.
The winners of the CPHI Pharma Awards 2026 include a neurodegeneration platform, a track-and-trace packaging innovation, a enzymatic mRNA manufacturing technology, and a cell-free enzymatic biomanufacturing platform.
Richard Jaenisch explains why NAMs are compressing drug development faster than AI and what FDA's new nonclinical testing rule means for sponsors.
Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
Ron Scarboro, Azurity Pharmaceuticals, claims drug reformulation that removes patient barriers must preserve efficacy, urging early cross-functional team alignment.
Advertisement
Advertisement