SOUTH SAN FRANCISCO, Calif.,
April 17, 2017 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
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.
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. 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.
About Fostamatinib
Fostamatinib is an oral
investigational drug candidate with a unique mechanism of action
designed to inhibit SYK kinase, a key player 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 the
underlying autoimmune cause of ITP by impeding platelet
destruction.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc. 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. The company completed and reported results from the
Phase 3 clinical program for fostamatinib in chronic immune
thrombocytopenia (ITP) in 2016. Rigel is also conducting a Phase 2
clinical study with fostamatinib in autoimmune hemolytic anemia
(AIHA) and a Phase 2 clinical study for IgA nephropathy (IgAN). In
addition, Rigel has two oncology product candidates in development
with partners BerGenBio AS and Daiichi Sankyo.
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 "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 Annual Report on Form 10-K for the year
ended December 31, 2016. 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.