LEO Reports the US FDA’s Acceptance of BLA for Tralokinumab to Treat Adults with Moderate to Severe Atopic Dermatitis

 LEO Reports the US FDA’s Acceptance of BLA for Tralokinumab to Treat Adults with Moderate to Severe Atopic Dermatitis

LEO Reports the US FDA’s Acceptance of BLA for Tralokinumab to Treat Adults with Moderate to Severe Atopic Dermatitis

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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