SOUTH SAN FRANCISCO, Calif., Oct.
18, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc.
(Nasdaq: RIGL) today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA), has adopted a positive trend vote on the Marketing
Authorization Application (MAA) for fostamatinib disodium
hexahydrate (fostamatinib). The indication for the positive trend
vote is for the treatment of chronic immune thrombocytopenia in
adult patients who are refractory to other treatments.
"During the EMA review process for fostamatinib in adult chronic
ITP, we have had very constructive interactions with the
committee," said Raul Rodriguez,
president and CEO of Rigel. "We are pleased with this positive
trend vote from the CHMP this week, which brings us one step closer
to potentially providing a new therapeutic option for a patient
population that has a clear unmet clinical need."
The CHMP intends to hold a final vote on their recommendation at
their November meeting. Pending a formal positive CHMP opinion, the
European Commission, which has the authority to approve medicines
for use in Europe, would be
expected to render their decision approximately 60 days after the
opinion is received.
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, 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 (Thrombopoietin Receptor Agonists) 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), 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) and an ongoing Phase 1 study of
R835, a proprietary molecule from its interleukin receptor
associated kinase (IRAK) program. In addition, Rigel has product
candidates in clinical development with partners
BerGenBio ASA, Daiichi Sankyo, Aclaris Therapeutics, and
AstraZeneca.
Please see www.TAVALISSE.com for full Prescribing
Information.
Forward Looking Statements
This release contains forward-looking statements relating to,
among other things, the CHMP opinion and the potential
approval and subsequent 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," "intention," 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 June 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.