Januar 16, 2020

Grifols to launch TAVLESSE® in Europe and Turkey to continue reinforcing its commercial strategy and commitment to patients

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  • European Commission has approved TAVLESSE® (fostamatinib) for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments
  • Grifols gained exclusive rights to TAVLESSE® in ITP and other pipeline indications in Europe and Turkey as a result of the Collaboration and License Agreement reached with Rigel Pharmaceuticals in January 2019
  • TAVLESSE® launch expected to be in Q2 of this year, complements  Grifols’ product portfolio and would benefit patients and offer more therapeutic options for healthcare professionals 

Barcelona (Spain), January 16, 2020.- Grifols (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), one of world’s top three producers of plasma-derived medicines and a forerunner in the research and development of therapeutic alternatives that drive scientific and social advancements, today announced that the European Commission (EC) has approved US-based Rigel Pharmaceuticals’s (NASDAQ: RIGL) TAVLESSE® (fostamatinib) for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.

Grifols has exclusive rights to fostamatinib in chronic ITP, as well as any potential future indications like autoimmune hemolytic anemia (AIHA), and IgA nephropathy (IgAN), in Europe and Turkey.

Currently, fostamatinib is commercially available in the U.S. under the brand name TAVALISSE®, which is the first and only SYK (spleen tyrosine kinase) inhibitor indicated in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

The launch of TAVLESSE® in Europe and Turkey reinforces Grifols’ commercial strategy and reflects the company’s commitment to continue expanding its product portfolio to benefit patients and offer more therapeutic options for healthcare professionals.

About the chronic immune thrombocytopenia (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.  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.  Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.