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TAVALISSE® (Fostamatinib) Approved in Mexico for Chronic ITP Treatment

• Knight Therapeutics' Mexican affiliate receives regulatory approval for TAVALISSE® (fostamatinib) from COFEPRIS to treat thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP). • Fostamatinib, an orally administered spleen tyrosine kinase (SYK) inhibitor, offers a new therapeutic alternative for patients who have had an insufficient response to previous ITP treatments. • The approval marks a significant step in expanding treatment options for ITP patients in Latin America, with the launch of TAVALISSE® in Mexico expected in the first half of 2026.

Knight Therapeutics Inc. announced that its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V., has received regulatory approval from COFEPRIS for TAVALISSE® (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
The approval of fostamatinib introduces a novel treatment option for chronic ITP patients in Mexico. Dr. Luis Antonio Meillón García noted the challenges in treating chronic ITP due to the disease's diversity and the difficulty in predicting individual patient responses. Fostamatinib, with its innovative mechanism of action, offers physicians a new therapeutic alternative.

Mechanism of Action and Availability

Fostamatinib is an orally administered spleen tyrosine kinase (SYK) inhibitor. It is currently available in the United States as TAVALISSE® (100mg and 150mg tablets) and in Europe under the brand name TAVLESSE® for the treatment of adult chronic ITP with an insufficient response to a previous treatment. Knight Therapeutics secured exclusive rights to commercialize fostamatinib in Latin America through an agreement with Rigel Pharmaceuticals, Inc. on May 24, 2022.

Management Commentary

Samira Sakhia, President and CEO of Knight Therapeutics, expressed excitement about the approval of TAVALISSE® in Mexico, emphasizing its role in providing a vital new treatment option for adult patients with chronic ITP. The company anticipates launching TAVALISSE® in Mexico in the first half of 2026.

About Immune Thrombocytopenia (ITP)

ITP is an autoimmune condition where the immune system attacks and destroys the body's own blood platelets, which are crucial for blood clotting and healing. Common symptoms include excessive bruising and bleeding. Patients with chronic ITP face an increased risk of severe bleeding events, potentially leading to serious medical complications or even death. Current therapies include steroids, thrombopoietin receptor agonists (TPO-RAs), and splenectomy. However, many patients do not respond adequately to these existing treatments, highlighting the need for additional therapeutic options.
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Reference News

[1]
Knight Therapeutics Announces Regulatory Approval of TAVALISSE® in Mexico
finance.yahoo.com · Dec 12, 2024

Knight Therapeutics announced COFEPRIS approval for TAVALISSE® (fostamatinib) to treat chronic ITP in Mexico, offering a...

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