Knight Therapeutics Announces Regulatory Approval of TAVALISSE® in Brazil

MONTREAL, May 08, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltda., received regulatory approval from ANVISA for TAVALISSE® (fostamatinib disodium hexahydrate) for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.¹

"Fostamatinib 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,” said Dr. Ana Clara Kneese Nascimento, Professor at the Faculty of Medical Sciences of Santa Casa de São Paulo and hematologist responsible for the Platelet Outpatient Clinic of Santa Casa de São Paulo.

“We are excited to receive the approval of TAVALISSE in Brazil. 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,” said Samira Sakhia, President and CEO of Knight Therapeutics. “We expect the launch of TAVALISSE in Brazil in the second half of 2026.”

Knight announced its agreement with Rigel Pharmaceuticals, Inc. in May 2022, securing exclusive rights to commercialize fostamatinib in Latin America. In 2023, Knight submitted fostamatinib for regulatory approval in Colombia and in 2025 in Argentina and Paraguay. In December 2024, Knight also announced the regulatory approval for fostamatinib in Mexico and expects to launch commercially in the first half of 2026.

About TAVALISSE® (fostamatinib disodium hexahydrate)

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.²  

About ITP

In patients with ITP, the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding.³ People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death.⁴ Current therapies for ITP in Brazil include steroids, blood platelet production boosters like thrombopoietin receptor agonists (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies.⁵ As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About FIT trial

The approval was supported by two parallel, randomized, double‑blind, placebo‑controlled phase 3 trials, FIT‑1 and FIT‑2 (n=150), and the open‑label FIT‑3 extension. Patients received fostamatinib 100 mg twice daily for 24 weeks with an optional increase to 150 mg twice daily after one month.²

Across FIT‑1 and FIT‑2, the primary endpoint—stable platelet response (≥50 × 10⁹/L at ≥4 of 6 assessments during Weeks 14–24, without rescue therapy)— was achieved by 18% of patients on fostamatinib vs. 2% on placebo (P = .0003). Overall responses (defined retrospectively as ≥1 platelet count ≥50 000/μL within the first 12 weeks on treatment) occurred in 43% of patients on fostamatinib vs. 14% on placebo (P = .0006)⁶. In FIT‑3, 23% of patients newly treated with fostamatinib (treated with placebo in the prior studies) achieved a stable response.¹ Among the subjects who achieved stable response in FIT-1, FIT-2 and FIT-3 trials, 18 subjects maintained the platelet count of at least 50 x 10⁹/L for 12 months or longer.¹

The most common adverse reactions (≥5%) included diarrhea, hypertension, nausea, dizziness, elevated ALT/AST, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.⁶ Serious adverse drug reactions reported in 1% of patients included febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis.⁶

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight’s Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's website at www.knighttx.com or www.sedarplus.ca.

Forward-Looking Statements for Knight

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2025, as filed on www.sedarplus.ca. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.

References

1) ANVISA, Prescribing Information. Approved on May 7, 2026.
2) Tavalisse. Full Prescribing Information. Rigel Pharmaceuticals, 2018, www.tavalisse.com/downloads/pdf/Tavalisse-Full-Prescribing-Information.pdf.
3) National Heart, Lung, and Blood Institute. Immune Thrombocytopenia. U.S. Department of Health and Human Services, https://www.nhlbi.nih.gov/health/immune-thrombocytopenia. Accessed 24 July 2025.
4) Kos, Marek et al. “The Many Faces of Immune Thrombocytopenia: Mechanisms, Therapies, and Clinical Challenges in Oncological Patients.” Journal of clinical medicine vol. 13,22 6738. 8 Nov. 2024, doi:10.3390/jcm13226738
5) Kuter, D. "The treatment of immune thrombocytopenia (ITP) – focus on thrombopoietin receptor agonists" Annals of Blood, vol. 6, 2021. https://aob.amegroups.org/article/view/6335/html. Accessed 24 July 2025.
6) Bussel, James et al. “Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: Results of two phase 3, randomized, placebo-controlled trials.” American journal of hematology vol. 93,7 (2018): 921-930. doi:10.1002/ajh.25125

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