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Rigel Pharma submits NDA to US FDA for fostamatinib in patients with chronic ITP

South San Francisco, California
Thursday, April 20, 2017, 13:00 Hrs  [IST]

Rigel Pharmaceuticals  has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for fostamatinib in patients with chronic and persistent immune thrombocytopenia (ITP).

"This NDA submission in support of fostamatinib in ITP is a major milestone in bringing new treatment options to patients suffering from this disease," said Raul Rodriguez, Rigel's president and chief executive officer. "We look forward to working closely with the FDA as they review the submission over the coming months."

The NDA is supported by data from the phase 3 clinical programme for fostamatinib in ITP, which was comprised of three studies, two randomized placebo-controlled studies (Studies 047 and 048) and an open-label extension study (Study 049). In total, 163 ITP patients have been evaluated and included in the NDA submission. Across all indications, fostamatinib has been evaluated in over 4,600 subjects.  Data from all studies, including preclinical evaluation and drug manufacturing data, were included in the NDA submission. The Company expects to receive notification regarding the acceptance of the NDA by the FDA in June 2017.

The FDA previously granted Orphan Drug designation to fostamatinib for the treatment of patients with 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 increased risk of severe bleeding events that can result in serious medical complication, or even death.  Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. However, a portion of patients do not derive a benefit from existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.  

Rigel Pharmaceuticals is a clinical-stage biotechnology company dedicated to the discovery and development of novel, targeted drugs in the therapeutic areas of immunology, oncology and immuno-oncology. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's current clinical programs include clinical studies of fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor in a number of indications.


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