A new drug for adhesion dermatitis (AD) ! Leo Pharmaceuticals Anti-IL-13 Monotarokinumab: The first challenger of Nofi Dupixent biopharmaceuticals!

11, 2020 // Leo Pharma, a Danish pharmaceutical company, recently announced that the U.SFood and Drug Administration (FDA) has accepted a biological product licensing application (BLA) for tralokinumab, a drug used to treat adult patients with moderate to severe adhesional dermatitis (AD)FDA has initiated a formal review of the BLA, with the Prescription Drug User Charges (PDUFA) target date for the second quarter of 2021June this year, the European Medicines Agency (EMA) also received marketing authorization applications (MAAs) for adult patients with moderate to severe AD treatments in tralokinumab, which is under regulatory review by the Human Pharmaceutical Products Board (CHMP)if approved, tralokinumab will be the first biological agent to challenge Nofi/Regenerative Dupixent,which is currently a leading product and the only biological agent in the treatment of atopic dermatitis (AD)-specific dermatitis (AD) is a chronic, inflammatory, inflammatory skin disease characterized by severe itching and eczemaAD is the result of chronic inflammation caused by skin barrier dysfunction and immune disorderstype 2 cytokines, including leukocyte interleukin 13 (IL-13), play a central role in key aspects of AD pathophysiologytralokinumab is an all-human IgG4 monoclonal antibody that works through strong, specific neutralizing interleukin 13 (IL-13)IL-13 is an important cytokine that plays a key role in driving the internal inflammation of ad hoc dermatitisby binding IL-13 with high affinity specificity, tralokinumab blocks the interaction of IL-13 with its receptors and subsequent downstream IL-13 signal conductiontralokinumab is licensed by Leo Pharmaceuticals from AstraZenecaJuly 2016, the two sides reached a $1 billion deal to license two dermatology assets, tralokinumab and brodalumab, to Leo Pharmaceuticalsdivestiture, AstraZeneca aims to further focus its business on three core areas - oncology, respiratory, cardiovascular and kidneys and metabolismof the two antibody drugs approved for this grant, brodalumab was approved by the European Union in July 2017 for the treatment of adult patients with moderate to severe plaque type psoriasisin recent years, Leo Pharmaceuticals has continued to develop in the field of dermatologyin 2019, the company expanded its partnership with Elektrofi to develop innovative drug administration for dermatology antibody drugs using the latter's particle aerosol formulation technology (ElektrojectTM) for high-dose antibody treatment in a relatively small volume within seconds in addition to , the company completed the acquisition of Bayer's prescription dermatology business the end of 2019, Leo Pharmaceuticals also expanded its partnership with HitGen, which authorized a number of small molecular compounds from Chengdu Pilot, which is an undisclosed dermatological target provided by Chengdu Pilot sifting through its proprietary DNA-coded library (DEL) screening as the project progresses, Chengdu Pilot is eligible for related pre-clinical and clinical milestone payments and royalties -specific dermatitis (photo: icresearch.net) this tralokinumab BLA submission is based on data from three critical Phase III studies (ECZTRA 1, 2, 3) The first two were randomized, double-blind, placebo-controlled, multi-country 52-week studies, which included 802 patients and 794 patients, respectively, and evaluated the efficacy and safety of tralokinumab (300 mg, subcutaneous injection) in adults with moderate to severe AD treatment 3rd is a double-blind, randomized, placebo-controlled, multi-country 32-week study that evaluated the efficacy and safety of tralokinumab (300 mg, subcutaneous injection) in combination with local corticosteroid hormone (TCS) in adult patients with moderate to severe AD treatment results showed that all three studies reached the primary and secondary endpoints the main endpoints of the include: The 16th week of treatment investigator's comprehensive assessment (IGA) for complete removal of skin damage (IGA score is 0) or almost complete removal of skin loss (IGA score is 1), treatment week 16 eczema area and severity index (EASI) score improved by 75% compared to the baseline secondary endpoints include: changes in the epithelial dermatitis (SCORAD), itching numerical assessment scale (NRS) of at least 4 points from the baseline check to the 16th week, and the dermatology quality of life index (DLQI) study, the overall adverse event rates of tralokinumab and placebo were comparable these results show that tralokinumab is an effective and well-tolerated long-term treatment for adult patients with moderate to severe AD "There is an important unmet medical need in patient groups that are still out of control with moderate to severe adhesion dermatitis," said Dr Kim Kj?ller, Executive Vice President of Global Research and Development at Leo Pharmaceuticals if approved, tralokinumab would be the first biologic to specialize in neutralized IL-13 cytokines and, most importantly, provide a more targeted treatment for adults with the debilitating disease we will continue to work with regulatory agencies in the Us and the United States to bring this innovative treatment to patients as soon as possible " () Original source: LEO Pharma announces U.S Food and Drug Administration (FDA) acceptance of Biologics License (BLA) for the treatment of the treatment of adults with moderate-to-severe atopic dermatitis.