The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of fostamatinib disodium hexahydrate (Tavalisse, Rigel Pharmaceuticals, Inc) to treat adults with chronic immune thrombocytopenia (ITP) who fail other treatments.
ITP is an acquired immune-mediated disorder characterized by destruction of platelets and impaired platelet production. People with chronic ITP are at increased risk for severe bleeding events that can result in serious medical complications or death.
Current therapies for ITP include steroids, blood platelet production boosters, and splenectomy. However, not all patients are adequately treated with existing therapies and there remains a need for additional treatment options for patients with ITP, Rigel said in a news release.
Fostamatinib, a spleen tyrosine kinase inhibitor, helps increase and maintain platelet count and reduce bleeding risk, EMA said in a statement.
The CHMP positive opinion was based on data from two randomized, placebo-controlled phase 3 trials and an open-label extension trial. The marketing application included data from 163 ITP patients and was supported by a safety database of more than 4600 patients across all other indications in which fostamatinib has been evaluated, the company said.
The most common side effects are dizziness, diarrhea, nausea, frequent bowel movement, hypertension, and blood pressure abnormalities and liver function test abnormalities.
Fostamatinib is already approved in the United States for treatment of thrombocytopenia in adults with chronic ITP who have had an insufficient response to a previous treatment.
Once approved in Europe, fostamatinib will be available as 100-mg and 150-mg film-coated tablets. The drug should be prescribed by physicians experienced in the treatment of hematological diseases, EMA said.
Detailed recommendations for the use of fostamatinib will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.
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Cite this: EMA Panel Backs Fostamatinib (Tavalisse) for Chronic ITP - Medscape - Nov 15, 2019.
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