SOUTH SAN FRANCISCO, Calif.,
Oct. 2, 2017 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced
that during the company's mid-cycle meeting with the U.S. Food
and Drug Administration (FDA) the FDA indicated that, at this
point, it is not planning to hold an Oncology Drugs Advisory
Committee (ODAC) meeting to discuss the New Drug Application (NDA)
for fostamatinib in patients with chronic or persistent immune
thrombocytopenia (ITP). Additionally, the FDA indicated that
it anticipates meeting the Prescription Drug User Fee Act (PDUFA)
action date for the application review, which is April 17, 2018. In an earlier communication, the
FDA had conditionally approved the proprietary name
TavalisseTM.
"Since we submitted our NDA this spring, we have worked
collaboratively with the FDA to answer routine questions as they
arise," said Anne-Marie Duliege, MD, executive vice president and
chief medical officer of Rigel. "Our positive interactions with the
FDA, including their customary biomedical monitoring (BIMO)
inspections at our facilities and clinical sites, are in-line with
our expectations and have progressed well. We will continue to work
closely with the agency and remain committed to bringing
fostamatinib to patients with ITP who are in need of new treatment
options."
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 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 and the FDA has accepted for review, an NDA 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
FDA's indication that it is not planning to hold an ODAC meeting to
discuss the NDA for fostamatinib in patients with chronic or
persistent ITP, the timing of the FDA's application review of 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," "hope" 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 later decide to hold an
ODAC meeting; delays in the FDA's review of the submitted NDA by
the PDUFA action date; 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; 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 June 30,
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.