Rigel Pharmaceuticals announced the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion for Rigel's Marketing Authorization Application (MAA) for fostamatinib disodium hexahydrate (fostamatinib) for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments.
The CHMP reviews medical product applications and provides their opinion to the European Commission (EC), which has the authority to approve medicines for use in Europe. The positive opinion will now be reviewed by the EC, which will issue a decision on the approval of fostamatinib in Europe within approximately 70 days.
"We are extremely encouraged by the CHMP's positive opinion and look forward to the final decision on our MAA from the European Commission," said Raul Rodriguez, Rigel's president and CEO. "We are excited by the potential to provide adult chronic ITP patients in Europe with a new treatment option that addresses the primary cause of their disease. Our European partner, Grifols, is preparing diligently for a prospective commercial launch in 2020."
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The CHMP based its opinion on data provided from the FIT Phase 3 clinical program, which included two randomized placebo-controlled trials (FIT1 and FIT2) and an open-label extension trial (FIT3). The MAA included data from 163 ITP patients and was supported by a safety database of more than 4,600 subjects across all other indications in which fostamatinib has been evaluated.
Fostamatinib is commercially available in the U.S. and is the first and only spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in U.S. adult patients with chronic ITP who have had an insufficient response to a previous treatment. Europe is the second largest market for adult chronic ITP treatments after the United States.
In patients with ITP (immune thrombocytopenia), 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 are adequately treated with existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.