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NICE recommends Grifols’ Tavlesse for chronic immune thrombocytopenia

Patients with chronic ITP may live with an increased risk of severe bleeding events


The National Institute for Health and Care Excellence (NICE) has recommended Grifols’ Tavlesse (fostamatinib) as a treatment for chronic immune thrombocytopenia (ITP) in adult patients refractory to other treatments.

ITP is a rare autoimmune condition characterised by the destruction of platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding, and those with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or, in some cases, death.

Current therapies for ITP include steroids, blood platelet production boosters, thrombopoietin receptor agonists (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies, underpinning the need for additional treatment options.

According to Grifols, Tavlesse is ‘the first and only spleen tyrosine kinase inhibitor for this indication’ and ‘the only targeted agent that works by protecting platelets from destruction’.

With NICE’s recommendation, which is specifically for patients who have previously had a TPO-RA, or who are unable to receive a TPO-RA, Tavlesse can now be accessed and reimbursed by the NHS across the UK.

"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.

NICE noted that Tavlesse was effective compared with a placebo, but that there is currently no clinical trial evidence directly comparing the drug with rituximab or mycophenolate. The agency’s recommendation was based on cost-effectiveness estimates of Tavlesse compared with rituximab.

Tavlesse is already available in Czech, French, German, Italian, Norwegian and Spanish markets, the company said. The drug has also received the go-ahead from the Scottish Medicines Consortium, which advised acceptance of the treatment last year.

“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.

Mervyn Morgan, chief executive officer of the UK and Ireland Support Association (ITPSA), added: “This is wonderful news and will be welcomed by ITP patients across the country. [Tavlesse] will be another tool for haematologists to use in supporting patients with chronic ITP.”

Article by
Emily Kimber

20th October 2022

From: Research, Regulatory



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