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# FDA Accepts for Review Leo’s Talokinumab BLA
- URL: https://www.fdaweb.com/fda-accepts-for-review-leos-talokinumab-bla/
- Published: 2020-07-09T12:00:00.000Z
- Updated: 2026-09-14T16:20:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147165

FDA has accepted for review Leo Pharma’s BLA for tralokinumab for treating adults with moderate to severe atopic dermatitis. A company [statement](https://www.businesswire.com/news/home/20200709005412/en/LEO-Pharma-announces-U.S.-Food-Drug-Administration/?feedref=JjAwJuNHiystnCoBq%5Fhl-QyNsUQ29c24MKpwrFSKUOTZQK86VRF04E6aMvZHPoaH7fxFuNFTHSunhvli30RlBNXya2izy9YOgHlBiZQk2LP6oD-t3eB0qV-nJQ-WeFyCEq7XOd8em%5FUy42DWNTo2Mw==&ref=fdaweb.com) says FDA has set a PDUFA target action date in the second quarter of 2021.

Leo describes tralokinumab as a fully human monoclonal antibody that specifically neutralizes the interleukin-13 cytokine that is a key driver of the underlying inflammation in atopic dermatitis. It says the BLA is based on data from the pivotal ECZTRA 1, 2, and ECZTRA 3 Phase 3 studies evaluating the drug’s safety and efficacy.