Tavalisse prepares to launch as treatment for ITP in Brazil, Mexico
Regulators in Brazil approve oral therapy for certain patients
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Regulatory authorities in Brazil have approved the oral therapy Tavalisse (fostamatinib disodium hexahydrate) for adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a prior treatment.
“[Tavalisse] is an effective and well-tolerated new treatment option that addresses an unmet need in Brazil for ITP patients who have had an insufficient response to their treatment and remain at risk of bleeding,” Ana Clara Kneese Nascimento, MD, a professor at Brazil’s Santa Casa de São Paulo, said in a press release from Knight Therapeutics.
Knight holds rights to market Tavalisse in Latin America as part of a 2022 agreement with the therapy’s developer Rigel Pharmaceuticals, which sells it in the U.S. Knight said it expects Tavalisse to be commercially available in Brazil in the second half of this year.
The company also plans to launch Tavalisse in Mexico this year. The therapy has been approved in that country since late 2024.
Enzyme blocking
“We are excited to receive the approval of Tavalisse in Brazil,” said Samira Sakhia, Knight’s president and CEO. “The approval of Tavalisse not only provides a new treatment option with a different mechanism of action for adult patients with chronic ITP but also demonstrates Knight’s ability to address the complex regulatory requirements of the health agencies across all our countries.”
ITP is an autoimmune disorder that leads to the destruction of platelets, cell fragments that help blood clot. Low platelet counts mean blood cannot clot properly, leading to symptoms such as unusual bleeding. Tavalisse works by blocking the activity of spleen tyrosine kinase (SYK), an enzyme that plays a key role in the activity of immune cells that drive the disease.
The drug approvals were based primarily on data from two Phase 3 clinical trials, FIT-1 (NCT02076399) and FIT-2 (NCT02076412). These studies tested Tavalisse against a placebo in 150 people with ITP whose condition was not well managed with prior treatments, and results showed the therapy was significantly better than the placebo at increasing platelet counts. Many participants who completed the placebo-controlled studies entered an extension trial, FIT-3 (NCT02077192), which showed consistent safety and efficacy with long-term Tavalisse treatment.
