Knight Therapeutics Announces Regulatory Approval of NIKTIMVO® in Brazil
Key Highlights
- ➤NIKTIMVO receives expedited ANVISA approval for cGVHD in Brazil
- ➤Approval covers adults and children aged 6 years and older weighing at least 40 kg
- ➤Knight holds exclusive Latin American distribution rights for NIKTIMVO
- ➤Brazil records approximately 1400–1800 allogeneic transplants annually
- ➤Axatilimab Phase 2 and Phase 3 combination trials in cGVHD are underway
Expert Statements
Samira Sakhia, President and CEO of Knight Therapeutics
“For patients living with chronic graft-versus-host disease who have exhausted two prior lines of therapy, access to a new treatment option can be life-changing. NIKTIMVO(®) offers a first-in-class mechanism that targets the underlying drivers of this debilitating condition, and we are proud to bring it to patients in Brazil. This approval reflects the strength of our partnership with Incyte and our shared commitment to ensuring that patients in Brazil have access to innovative therapies that can make a meaningful difference in their lives”
MONTREAL, Oct. 06, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. ("Knight") (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today it has received expedited regulatory approval under ANVISA’s rare disease pathway for NIKTIMVO(®) (axatilimab), for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients 6 years and older weighing at least 40 kg.(1)
“For patients living with chronic graft-versus-host disease who have exhausted two prior lines of therapy, access to a new treatment option can be life-changing. NIKTIMVO(®) offers a first-in-class mechanism that targets the underlying drivers of this debilitating condition, and we are proud to bring it to patients in Brazil. This approval reflects the strength of our partnership with Incyte and our shared commitment to ensuring that patients in Brazil have access to innovative therapies that can make a meaningful difference in their lives,” said Samira Sakhia, President and CEO of Knight Therapeutics.
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