LEO Pharma announces FDA approval of Adbry

Privately-held Danish dermatology specialist LEO Pharma yesterday revealed that the US Food and Drug Administration has approved Adbry (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The approval comes despite a complete response letter issued by the FDA in April.

Adbry, which can be used with or without topical corticosteroids, is the first and only FDA approved biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine, a key driver of atopic dermatitis signs and symptoms, the company noted.

“Today’s FDA approval of Adbry is a major milestone for LEO Pharma and for the millions of people living with moderate-to-severe atopic dermatitis who struggle to find effective control for this chronic and debilitating disease,” said Anders Kronborg, chief financial officer and acting chief executive of LEO Pharma, adding: “As our first biologic in the US, Adbry signifies important progress in our mission of advancing the standard of care in medical dermatology.”