July 9, 2020

Grifols starts commercializing TAVLESSE® in Europe, diversifying its medicines portfolio

  • European customers begin receiving TAVLESSE® (fostamatinib) for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments
  • Grifols’ first oral therapy from Bioscience Division to expand and diversify portfolio to benefit patients and offer more therapeutic options for healthcare professionals

Barcelona, July 9, 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 it has begun European delivery of TAVLESSE® (fostamatinib) to treat chronic immune thrombocytopenia (ITP) in adult patients refractory to other treatments.

This is the first non-plasma product that the company’s flagship Bioscience Division has launched in Europe. Over time Grifols expects to further strengthen and complement its industry-leading portfolio through additional innovative in-licensing agreements to treat existing and emerging diseases, benefiting patients and offering additional therapeutic alternatives to healthcare providers.

TAVLESSE® is already available in Germany and the UK, with a phased rollout across the rest of Europe planned over the next 18 months before expanding into Turkey.

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 thanks to a Collaboration and License Agreement reached with U.S.-based Rigel Pharmaceuticals in January 2019.

Fostamatinib is also commercially available in the U.S. under the brand name TAVALISSE®, 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.

Early this year the European Commission approved TAVLESSE® to treat ITP in adult patients refractory to other treatments.

About 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.