Knight Therapeutics has announced the regulatory submission of Niktimvo (axatilimab) in Brazil for the treatment of chronic graft-versus-host disease (cGvHD), marking another step in the therapy’s geographic expansion beyond its initial approvals in major established markets. In the US, Niktimvo was approved by the FDA in August 2024 for adult and pediatric patients with cGvHD. The Brazilian submission on 18 February 2026 reflects Knight’s broader strategy to extend access across Latin America and aligns with the company’s amended supply and distribution agreement with Incyte, under which Knight holds exclusive rights to distribute both axatilimab (Niktimvo) and retifanlimab in Latin America, with Incyte responsible for development, manufacturing, and supply.
Chronic GvHD is a serious complication of allogeneic haematopoietic stem cell transplantation (HSCT). The condition can affect multiple organ systems, including the skin, liver, gastrointestinal tract, and lungs, and is associated with substantial morbidity and reduced quality of life. Although corticosteroids remain the cornerstone of first-line treatment, a significant proportion of patients develop steroid-refractory disease, necessitating alternative systemic therapies.
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Niktimvo is a monoclonal antibody that targets and inhibits colony-stimulating factor-1 receptor (CSF-1R), thereby blocking cellular signalling pathways that result in macrophage activation and fibrotic processes associated with chronic GvHD. By affecting these cellular processes, axatilimab is designed to address underlying immune dysregulation rather than relying solely on broad immunosuppression. This mechanism-driven approach reflects the broader shift in chronic GvHD management toward targeted immunomodulatory therapies.
From a market perspective, the Brazilian submission underscores the growing importance of emerging markets in the lifecycle strategy of speciality biologics. Brazil represents the largest pharmaceutical market in Latin America and has an established transplant infrastructure supported by specialised haematology and oncology centres. Regulatory approval could facilitate structured adoption within transplant networks, though uptake will depend on pricing, reimbursement negotiations, and formulary positioning.
The submission also reflects a broader competitive dynamic within the chronic GvHD landscape, where companies are pursuing differentiated mechanisms of action to complement or compete with established systemic agents. Expanding geographic access early in the product lifecycle may enhance commercial positioning and support revenue diversification beyond core North American and European markets.
Overall, the Brazilian filing of axatilimab highlights the intersection of transplant growth, biologic innovation, and emerging market expansion. As chronic GvHD management continues to evolve, geographic expansion strategies will play an increasingly important role in shaping long-term commercial performance and patient access.
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By GlobalData
