Rigel Pharmaceuticals, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. 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 program 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.