Knight Therapeutics' TAVALISSE Receives Approval in Colombia for ITP Treatment
MONTREAL, Sept. 01, 2026 /CourierPR/ -- Knight Therapeutics has announced that its drug TAVALISSE® has received regulatory approval in Colombia, marking a significant step forward in the treatment of chronic immune thrombocytopenia (ITP) for adult patients. The approval by INVIMA, Colombia's health regulatory agency, paves the way for the drug to become available to patients and healthcare providers in the country in the coming months.
"Regulatory approval of TAVALISSE in Colombia is a milestone for our company and for patients living with chronic ITP," said Samira Sakhia, President and CEO of Knight Therapeutics. "This approval underscores our commitment to expanding access to innovative treatments and improving patient outcomes across Latin America."
Knight Therapeutics acquired exclusive rights to commercialize TAVALISSE in Latin America through an agreement with Rigel Pharmaceuticals in May 2022. Since then, the company has been actively pursuing regulatory approvals across the region. TAVALISSE, an orally administered spleen tyrosine kinase (SYK) inhibitor, is already marketed in the United States and Europe under the brand name TAVALISSE for the treatment of chronic ITP.
The drug was recently approved in Mexico in May 2026, and Knight Therapeutics expects to launch it in Brazil in the fourth quarter of 2026. The Colombian approval is set to follow soon, with the company planning to make the drug available to patients in the first half of 2027.
Chronic immune thrombocytopenia (ITP) is a condition where the immune system mistakenly attacks and destroys blood platelets, leading to an increased risk of excessive bruising and bleeding. The disease can significantly impact a patient's quality of life and, in severe cases, can lead to serious medical complications or even death.
TAVALISSE works by inhibiting spleen tyrosine kinase (SYK), a protein that plays a crucial role in the immune system's response to platelets. This mechanism of action helps reduce the destruction of platelets, thereby improving blood clotting and healing.
"This approval is particularly significant for patients in Colombia who have not responded well to other treatments," added Sakhia. "TAVALISSE offers a new therapeutic option that could significantly improve their quality of life."
Knight Therapeutics, headquartered in Montreal, Canada, focuses on acquiring, in-licensing, and commercializing pharmaceutical products for both Canada and Latin America. The company's subsidiaries in Latin America operate under the names United Medical, Biotoscana Farma, and Laboratorio LKM. Knight Therapeutics' shares trade on the TSX under the symbol GUD.
The approval of TAVALISSE in Colombia is a testament to the company's ongoing efforts to expand access to innovative treatments in Latin America. As the drug becomes available in more countries, it is expected to provide a valuable new treatment option for patients with chronic ITP, addressing an unmet medical need in the region.