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Highlights
- Grupo Biotoscana de Especialidad S.A. de C.V., has received regulatory approval from COFEPRIS for TAVALISSE® (fostamatinib disodium hexahydrate).
- The approval is for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to previous treatments.
- TAVALISSE® is an orally administered spleen tyrosine kinase (SYK) inhibitor, offering a new therapeutic option for ITP patients in Mexico.
Knight Therapeutics Inc. (TSX:GUD), a pan-American specialty pharmaceutical company, is pleased to announce that its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V., has received regulatory approval from COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) for the use of TAVALISSE® (fostamatinib disodium hexahydrate) in the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP). This approval provides a new, much-needed treatment option for patients in Mexico who have not responded sufficiently to previous therapies.
A New Treatment Option for Chronic ITP
Chronic ITP is a condition where the immune system mistakenly attacks the body's platelets, leading to low platelet counts and a higher risk of severe bleeding. Patients suffering from this disease experience symptoms such as excessive bruising and bleeding, and may face serious complications, including life-threatening events. Current treatments for ITP include steroids, thrombopoietin receptor agonists (TPO-RAs), and splenectomy. However, not all patients respond to these options, creating a significant unmet need for alternative therapies.
Dr. Luis Antonio Meillón García, a hematologist and medical doctor at Centro Médico ABC in Mexico, commented, “Treating chronic ITP is challenging due to the disease's diversity, making it difficult to predict individual patient responses to available treatments. The approval of fostamatinib by COFEPRIS offers physicians a new therapeutic alternative with an innovative mechanism of action.”
About TAVALISSE®
TAVALISSE® (fostamatinib) is an orally administered spleen tyrosine kinase (SYK) inhibitor, designed to modulate the immune response that leads to the destruction of platelets in ITP. It is already available in the United States and Europe under the brand name TAVALISSE® (100mg and 150mg tablets) and TAVLESSE®, respectively. The drug provides a new treatment option for adult patients with chronic ITP who have had an insufficient response to previous therapies.
Knight Therapeutics had previously entered into an agreement with Rigel Pharmaceuticals, Inc. on May 24, 2022, securing the exclusive rights to commercialize fostamatinib in Latin America, including Mexico.
Expansion in Latin America
“We are excited to receive the approval of TAVALISSE® in Mexico, providing a vital new treatment option for adult patients with chronic ITP,” said Samira Sakhia, President and CEO of Knight Therapeutics. “This milestone not only marks an important step in expanding treatment options for ITP patients but also reinforces our commitment to improving patient outcomes across Latin America. We expect the launch of TAVALISSE® in Mexico in the first half of 2026.”
With this approval, Knight Therapeutics is expanding its presence in the Latin American market and addressing a critical medical need for patients with chronic ITP. The company plans to launch TAVALISSE® in Mexico in 2026, bringing a new hope for those affected by this debilitating condition.
About ITP (Immune Thrombocytopenia)
Immune Thrombocytopenia (ITP) is an autoimmune disorder where the body's immune system attacks and destroys its own platelets, which are essential for blood clotting and wound healing. This results in thrombocytopenia, or low platelet counts, leading to an increased risk of bruising, bleeding, and other serious complications. Current treatments such as steroids, TPO-RAs, and splenectomy can be effective but are not suitable for all patients, making new treatment options critical.
The approval of TAVALISSE® marks a significant step toward addressing the unmet needs of chronic ITP patients, particularly those who have not responded to existing treatments.
About Knight Therapeutics
Knight Therapeutics Inc. is a pan-American specialty pharmaceutical company, with a focus on marketing and distributing prescription drugs in Latin America. The company is committed to bringing innovative therapies to market and improving patient outcomes in the region.
