Following its analysis of LEO Pharma’s Tralokinumab, the US Food and Drug Administration (FDA) sent a Complete Response Letter (CRL). The recently concluded Biologics License Application (BLA) analysis raised the question of more data on a system portion rather than the safety and efficacy of Tralokinumab.
Jörg Möller, Executive Vice President for Global R and D at LEO Pharma, said, “The FDA has not raised any questions to the clinical efficacy or safety of Tralokinumab, but only requested additional data relating to a device component of the combination product. We will now work closely with the FDA to address their request and bring to the U.S. patients as quickly as possible.”
This disease may have debilitating physical effects and even lead to mental health problems if it is allowed to progress to a moderate or serious stage. The proteins IL-13 and IL-4 are crucial in the inflammation that underpins A.D. Although A.D. is thought to be a heightened, even rare immune response, it is not always classified as an autoimmune disorder. It is, instead, an atopic disorder.
LEO Pharma’s asset will provide A.D. patients with a novel treatment option. Tralokinumab is an antibody that targets and neutralises the cytokine IL-13. The biologic effectively avoids an overreaction of the immune system to allergens by blocking this chemical messenger.