Rigel Pharmaceuticals submits NDA to FDA for Fostamatinib to treat chronic ITP
Rigel Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for an oral investigational drug candidate, Fostamatinib, for the treatment of chronic and persistent immune thrombocytopenia (ITP).
In ITP, the immune system attacks and destroys the body's own blood platelets, resulting in excessive bruising and bleeding.
Fostamatinib is designed to inhibit SYK kinase, a key component in the immune process that leads to platelet destruction in ITP.
Rigel Pharmaceuticals president and chief executive officer Raul Rodriguez said: “This NDA submission in support of fostamatinib in ITP is a major milestone in bringing new treatment options to patients suffering from this disease.
“We look forward to working closely with the FDA as they review the submission over the coming months.”
The NDA includes data from the Phase III clinical programme for Fostamatinib in both ITP and data procured from all studies, including preclinical evaluation and drug manufacturing data.
This Phase III clinical programme evaluated 163 ITP patients and includes three studies, two randomised placebo-controlled studies (Studies 047 and 048) and an open-label extension study (Study 049).
In total, fostamatinib has been evaluated in more than 4,600 subjects across all indications.
Rigel expects to receive notification regarding the acceptance of the NDA from FDA by June this year.
FDA previously granted Orphan Drug designation to fostamatinib to treat ITP patients.