SOUTH SAN FRANCISCO, Calif.,
Nov. 15, 2019 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced
that the Committee for Medicinal Products for Human Use (CHMP), the
scientific committee of the European Medicines Agency, has adopted
a positive opinion for Rigel's Marketing Authorization Application
(MAA) for fostamatinib disodium hexahydrate (fostamatinib) for the
treatment of chronic immune thrombocytopenia in adult patients who
are refractory to other treatments.
The CHMP reviews medical product applications and provides their
opinion to the European Commission (EC), which has the authority to
approve medicines for use in Europe. The positive opinion will now be
reviewed by the EC, which will issue a decision on the approval of
fostamatinib in Europe within
approximately 70 days.
"We are extremely encouraged by the CHMP's positive opinion and
look forward to the final decision on our MAA from the European
Commission," said Raul Rodriguez,
Rigel's president and CEO. "We are excited by the potential to
provide adult chronic ITP patients in Europe with a new treatment option that
addresses the primary cause of their disease. Our European partner,
Grifols, is preparing diligently for a prospective commercial
launch in 2020."
The CHMP based its opinion on data provided from the FIT Phase 3
clinical program, which included two randomized placebo-controlled
trials (FIT1 and FIT2) and an open-label extension trial (FIT3).
The MAA included data from 163 ITP patients and was supported by a
safety database of more than 4,600 subjects across all other
indications in which fostamatinib has been evaluated.
Fostamatinib is commercially available in the U.S. and is the
first and only spleen tyrosine kinase (SYK) inhibitor indicated for
the treatment of thrombocytopenia in U.S. adult patients with
chronic ITP who have had an insufficient response to a previous
treatment. Europe is the second
largest market for adult chronic ITP treatments after the United States.
About ITP
In patients with ITP (immune
thrombocytopenia), 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 an increased risk of severe bleeding events that can
result in serious medical complications or even death.
Current therapies for ITP include steroids, blood platelet
production boosters (TPO-RAs) and splenectomy. However, not all
patients are adequately treated with 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
hematologic disorders, cancer and rare diseases. Rigel's pioneering
research focuses on signaling pathways that are critical to disease
mechanisms. The company's first FDA approved product is
TAVALISSE® (fostamatinib disodium hexahydrate) tablets,
the only oral spleen tyrosine kinase (SYK) inhibitor, for the
treatment of adult patients with chronic immune thrombocytopenia
who have had an insufficient response to a previous treatment.
Rigel's current clinical programs include a Phase 3 study of
fostamatinib in autoimmune hemolytic anemia (AIHA); a recently
completed Phase 1 study of R835, a proprietary molecule from its
interleukin receptor associated kinase (IRAK) program; and an
ongoing Phase 1 study of R552, a proprietary molecule from its
receptor-interacting protein kinase (RIP1) inhibitor program. In
addition, Rigel has product candidates in clinical development with
partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and
Daiichi Sankyo.
Forward Looking Statements
This release contains
forward-looking statements relating to, among other things, the
CHMP opinion and the potential approval and subsequent 2020
commercial launch in Europe of
fostamatinib for the treatment of chronic ITP, and the timing
thereof. 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 "potential," "will,"
"may," "expect," "prospective," 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, risks and uncertainties associated
with the commercialization and marketing of TAVALISSE; risks that
the FDA, EMA or other regulatory authorities may make adverse
decisions regarding fostamatinib; risks that TAVALISSE clinical
trials may not be predictive of real-world results or of results in
subsequent clinical trials; risks that TAVALISSE may have
unintended side effects, adverse reactions or incidents of misuses;
the availability of resources to develop Rigel's product
candidates; market competition; 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 September 30,
2019. 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: David Burke
Phone: 650.624.1232
Email: dburke@rigel.com
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SOURCE Rigel Pharmaceuticals, Inc.