Shots:

• The BLA submission is based on P-III ECZTRA 1 & 2 studies assessing tralokinumab (300mg- SC) as monothx. vs PBO in 804 & 794 adults with mod. to sev. AD who were candidates for systemic therapy for 52wks. respectively
• The submission also follows the P-III ECZTRA 3 study assesses the safety and efficacy of tralokinumab (300mg- SC) + TCS in 380 adults with mod. to sev. AD who were candidates for systemic therapy
• Tralokinumab is an IgG4 mAb act by neutralizing the IL-13 cytokine with its anticipated PDUFA date in Q2’21. The EMA has accepted MAA for tralokinumab and is under CHMP’s review for approval

Click here to read full press release/ article | Ref: PRNewswire | Image: GMP News