Rigel Pharmaceuticals' New Drug Application (NDA) for the use of Tavalisse in treating chronic or persistent immune thrombocytopenia (ITP) has been filed by the U.S. Food and Drug Administration.
"The FDA acceptance for filing of our NDA is an exciting milestone for Rigel," Raul Rodriguez, Rigel's president and chief executive officer, said in a statement. "If approved, we believe Tavalisse will provide a new treatment option for patients with chronic or persistent ITP. We look forward to working closely with the FDA as they review our submission."
The NDA should be decided upon by April 17, 2018 as per the Prescription Drug User Fee Act. Rigel believes the NDA submission is supported by data from three studies that evaluate Tavalisse – two randomized placebo-controlled studies (Studies 047 and 048), and an open-label extension study.
ITP affects patients by causing the immune system to attack and destroy the body’s own blood platelets, which help create blood clotting. Patients with ITP, therefore, often suffer from excessive bruising and bleeding.
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