Grifols’ TAVLESSE® (fostamatinib) receives NICE recommendation for treating refractory chronic immune thrombocytopenia

Barcelona, Spain, Oct. 19, 2022 - Grifols (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), a global leader in plasma medicines with more than 110 years contributing to the health and well-being of people, today announced that its drug TAVLESSE^® (fostamatinib), used to treat chronic immune thrombocytopenia (ITP) in adult patients refractory to other treatments,¹ is now recommended by the National Institute for Health and Care Excellence (NICE).

With NICE’s recommendation, specifically for those patients who have previously had a thrombopoietin receptor agonist (TPO-RA), or for whom a TPO-RA is unsuitable,² TAVLESSE^® can now be accessed and reimbursed by National Health Service across all the United Kingdom. Last year the Scottish Medicines Consortium advised acceptance of the treatment.³

Fostamatinib is the first and only SYK (spleen tyrosine kinase) inhibitor indicated for adult patients with chronic ITP who have had an insufficient response to previous treatments. It is the only targeted agent that works by protecting platelets from destruction.⁴

Grifols has worked in close collaboration with UK healthcare professionals and UK patient associations to ensure recognition of the unmet needs of patients with refractory ITP and the value of TAVLESSE. ^®

“We are delighted that fostamatinib is now available for our patients. It works in a very different way than other treatments for ITP and we are looking forward to using it,” said Dr. Nichola Cooper, a consultant at Imperial College Healthcare Trust in London.

Mervyn Morgan, CEO of the UK and Ireland Support Association (ITPSA), said: “This is wonderful news and will be welcomed by ITP patients across the country. Fostamatinib will be another tool for hematologists to use in supporting patients with chronic ITP.”

Despite the availability of several different therapeutic approaches with drugs having varying mechanisms of action, ITP is able to persist for a number of years.⁴  Fostamatinib represents a novel treatment approach that can be orally administered and requires minimal titration; reducing both clinical time and the need for professional healthcare support. It was shown to produce a rapid, durable response among patients with longstanding ITP who were considered difficult to treat having previously received other treatments. ⁴

“TAVLESSE^® is the first new drug for treating chronic ITP in over a decade, addressing the unmet needs of patients who live with this disease,” said Paula Blackmore, Managing Director Grifols UK. “Grifols is committed to providing medicines and solutions that enhance people’s quality of life and well-being.”

TAVLESSE^® is also available in Czech Republic, France, Germany, Italy, Norway and Spain. Grifols continues a phased rollout across the rest of Europe of the treatment, the first oral non-plasma therapy that the company’s flagship Biopharma Business Unit has launched in Europe.

Over time Grifols expects to further strengthen 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 also commercially available in the U.S. under the brand name TAVALISSE.^®

Grifols has exclusive rights to fostamatinib in chronic ITP in Europe, Turkey, Middle East, North Africa and CIS countries thanks to a Collaboration and License Agreement reached with U.S.-based Rigel Pharmaceuticals.

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 (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options.

References

1. Instituto Grifols S.A. Tavlesse^® (fostamatinib): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/tavlesse-epar-product-information_en.pdf [Last accessed: September 2022].
2. NICE Final Appraisal Document (FAD). Fostamatinib for treating refractory chronic immune thrombocytopenia, September 2022
3. SMC advice fostamatinib 100mg and 150mg film‐coated tablets (Tavlesse^®). January 2021
4. Newland A, McDonald V. Fostamatinib: a review of its clinical efficacy and safety in the management of chronic adult immune thrombocytopenia. Immunotherapy. 2020 Dec;12(18):1325-1340. doi: 10.2217/imt-2020-0215. Epub 2020 Oct 6. PMID: 33023353.