The FDA slapped Leo Pharma A/S’ BLA for IL-13 inhibitor tralokinumab with a complete response letter (CRL), making it the latest atopic dermatitis candidate to hit a regulatory setback in the U.S., following delays for three oral JAK inhibitor drugs earlier this month.
New articles highlighting phase III data on the IL-13 inhibitor tralokinumab from Leo Pharma A/S have shown that combining it with topical corticosteroids as needed was effective and well-tolerated in patients with moderate to severe atopic dermatitis.
Leo Pharma A/S, of Ballerup, Denmark, has eyed a stronger company presence in Asia during the past year and took a giant step to achieving it by signing a worldwide exclusive licensing agreement with Oneness Biotech Co. Ltd., of Taipei, Taiwan, and Microbio Shanghai Co. Ltd. to develop and commercialize FB-825 for treating atopic dermatitis and allergic asthma.
Leo Pharma A/S, of Ballerup, Denmark, has eyed a stronger company presence in Asia during the past year and took a giant step to achieving it by signing a worldwide exclusive licensing agreement with Oneness Biotech Co. Ltd., of Taipei, Taiwan, and Microbio Shanghai Co. Ltd. to develop and commercialize FB-825 for treating atopic dermatitis and allergic asthma.
