SOUTH SAN FRANCISCO, Calif.,
June 19, 2017 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
announced the U.S. Food and Drug Administration (FDA) has filed its
New Drug Application (NDA) for the use of TAVALISSE™ (fostamatinib
disodium) in patients with chronic or persistent immune
thrombocytopenia (ITP). Rigel expects the action date for the FDA
to complete its review will be April 17,
2018, under the Prescription Drug User Fee Act (PDUFA).
The FDA previously granted Orphan Drug designation to
TAVALISSE™ for the treatment of patients with ITP.
"The FDA acceptance for filing of our NDA is an exciting
milestone for Rigel," said Raul
Rodriguez, Rigel's president and chief executive officer.
"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 submission 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).
Together with an initial proof of concept study, the NDA included
163 ITP patients. 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.
About 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. Currently approved therapies for ITP include steroids,
blood platelet production boosters (TPO-RAs) and splenectomy.
However, not all patients derive a benefit from existing therapies.
As a result, there remains a significant medical need for
additional treatment options for patients with ITP.
About TAVALISSE™ (fostamatinib disodium)
TAVALISSE™ is
an oral investigational drug candidate designed to inhibit SYK
kinase, a key signaling member in the immune process that
leads to platelet destruction in ITP. Unlike other therapies
that modulate the immune system in different ways or stimulate
platelet production, fostamatinib may address an underlying
autoimmune cause of ITP by impeding platelet destruction.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to
discovering, developing and providing novel small molecule drugs
that significantly improve the lives of patients with immune and
hematological disorders, cancer and rare diseases. Rigel's
pioneering research focuses on signaling pathways that are critical
to disease mechanisms. The company's current clinical programs
include clinical trials of fostamatinib, an oral spleen tyrosine
kinase (SYK) inhibitor, in a number of indications. Rigel has
submitted an NDA to the FDA for fostamatinib in patients with
chronic or persistent immune thrombocytopenia (ITP). In addition,
Rigel has product candidates in development with partners BerGenBio
AS, Daiichi Sankyo and Aclaris Therapeutics.
Forward Looking Statements
This release contains
forward-looking statements relating to, among other things, the
timing of a response from the FDA to our NDA submission and Rigel's
belief that fostamatinib may be an attractive alternative for
patients with ITP. Any statements contained in this press
release that are not statements of historical fact may be deemed to
be forward-looking statements. Words such as "if," "planned,"
"will," "may," "expect," and similar expressions are intended to
identify these forward-looking statements. These forward-looking
statements are based on Rigel's current expectations and inherently
involve significant risks and uncertainties. Actual results and the
timing of events could differ materially from those anticipated in
such forward looking statements as a result of these risks and
uncertainties, which include, without limitation, the FDA may
interpret Rigel's findings differently, which could result in
the FDA not approving any submitted NDA; the availability
of resources to develop Rigel's product candidates; Rigel's need
for additional capital in the future to sufficiently fund Rigel's
operations and research; the uncertain timing of completion of and
the success of clinical studies; market competition, risks
associated with and Rigel's dependence on Rigel's corporate
partnerships; risks related to changes in estimated cash position
based on the completion of financial closing procedures and the
audit of Rigel's financial statements; as well as other risks
detailed from time to time in Rigel's reports filed with
the Securities and Exchange Commission, including its
Quarterly Report on Form 10-Q for the quarter ended March 31,
2017. Rigel does not undertake any obligation to update
forward-looking statements and expressly disclaims any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein.
Contact: Raul Rodriguez
Phone: 650.624.1302
Email: invrel@rigel.com
Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@inventivhealth.com
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SOURCE Rigel Pharmaceuticals, Inc.