Daewoong Pharmaceutical said on the 14th it applied to the Animal and Plant Quarantine Agency for marketing approval of a treatment for atopic dermatitis in companion dogs.
The product for which approval was requested was developed as a companion animal–only medicine using "Plodicitinib," a small-molecule new drug substance discovered in-house by Daewoong Pharmaceutical, and its safety and efficacy were confirmed through nonclinical and clinical studies.
Plodicitinib is the first JAK inhibitor–class atopic treatment for companion dogs developed in Korea. JAK inhibitors are drugs that block Janus kinase (JAK), which is involved in immune and inflammatory responses. Phase 3 was completed at the end of last year, and a Phase 1 clinical trial for a human medicine using the same ingredient is also underway in parallel.
In Phase 3, Plodicitinib showed improvement in skin lesions from week 2 of dosing, and the lesion severity index decreased from an average of 56 points to 35 points at week 12. Even in severe companion dogs, the improvement was greater than the comparator, and treatment effects were confirmed in cases that did not respond to or had diminished effects with existing JAK inhibitors. In addition, the immunoglobulin E (IgE) level in the treatment group decreased by more than 30% compared with the comparator, showing improvement in immunological markers.
The global market for animal atopic dermatitis treatments is projected to grow from $3.17 billion in 2024 (about 4.7 trillion won) to $6.7 billion in 2035 (about 10 trillion won). Following "Envlo Pet," for which it applied for marketing approval in Oct. last year, Daewoong Pharmaceutical plans to secure growth momentum based on research and development in the companion animal medicines field through the development of Plodicitinib.
Park Sung-su, CEO of Daewoong Pharmaceutical, said, "Plodicitinib was selected in 2022 as a task under the Ministry of Agriculture, Food and Rural Affairs' full-cycle industrialization technology development project for companion animals," adding, "We expect it could be a treatment alternative in areas not addressed by existing animal JAK inhibitors." He added, "We will continue to pursue label expansions using the JAK inhibitor mechanism, including autoimmune skin diseases."