SOUTH SAN FRANCISCO, Calif.,
April 17, 2018 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
announced that the U.S. Food and Drug Administration (FDA) approved
TAVALISSE™ (fostamatinib disodium hexahydrate) for the treatment of
thrombocytopenia in adult patients with chronic immune
thrombocytopenia (ITP) who have had an insufficient response to a
previous treatment. TAVALISSE is an oral spleen tyrosine kinase
(SYK) inhibitor that targets the underlying autoimmune cause of the
disease by impeding platelet destruction, providing an important
new treatment option for adult patients with chronic ITP.
Rigel plans to launch TAVALISSE in the United States in late May 2018.
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"Chronic ITP is challenging to treat because the heterogeneity
of the disease makes it difficult to predict how an individual
patient will respond to available treatments and not all patients
can find a treatment that works well for them," said James Bussel, M.D., professor emeritus of
pediatrics at Weill Cornell Medicine and the principal study
investigator on the FIT Phase 3 program. Dr. Bussel has served as a
consultant and paid member of the advisory board for Rigel
Pharmaceuticals, Inc. "The FDA approval of fostamatinib arms
physicians with a new treatment option, which works via a novel
mechanism."
The FDA approval of TAVALISSE was supported by data from the FIT
clinical program, which included two randomized placebo-controlled
Phase 3 trials (Studies 047 and 048) and an open-label extension
(Study 049), as well as an initial proof of concept study. The
New Drug Application (NDA) included data from 163 ITP patients and
was supported by a safety database of more than 4,600 subjects
across other indications in which fostamatinib has been
evaluated.
"People living with chronic ITP often feel they have an
invisible disease -- one that can not only impact quality of life,
but also be life threatening," said Caroline Kruse, executive director of the
Platelet Disorder Support Association, a patient advocacy
organization dedicated to ITP patients. "That's why we encourage
members of our community to learn about their disease, understand
treatment strategies, and seek support so that they can advocate
for their best care. The availability of a new treatment option
provides the ITP community with more choices."
Different Treatment Approach
TAVALISSE is designed to
inhibit SYK, a key signaling component in the body's immune
process that can lead to platelet destruction in ITP patients.
TAVALISSE may address an underlying autoimmune cause of ITP by
impeding platelet destruction.
"We are excited to bring this new medicine to the population of
adult patients with chronic ITP in need of additional therapies. I
want to thank the patients, caregivers and physicians who
contributed to our fostamatinib clinical program, and also the
Rigel team for all of their dedication and hard work to bring the
company to this historic day," said Raul
Rodriguez, president and CEO of Rigel Pharmaceuticals.
"This regulatory milestone, our first product approval, validates
the therapeutic effect of SYK inhibition in an autoimmune
disease."
Rigel will be providing product information at the ASCO Annual
Meeting being held June 1-5, 2018 in
Chicago, Booth #24160, or you can
visit www.TAVALISSE.com.
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 include excessive bruising, bleeding and fatigue. 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 (TPOs) and
splenectomy. However, not all patients have an adequate treatment
response with existing therapies. As a result, there remains a
significant medical need for additional treatment options for
patients with ITP.
About TAVALISSE
Indication
TAVALISSE™ (fostamatinib disodium hexahydrate) tablets
is indicated for the treatment of thrombocytopenia in adult
patients with chronic immune thrombocytopenia (ITP) who have had an
insufficient response to a previous treatment.
Important Safety Information
Warnings and
Precautions
- Hypertension can occur with TAVALISSE treatment. Patients with
pre-existing hypertension may be more susceptible to the
hypertensive effects. Monitor blood pressure every 2 weeks until
stable, then monthly, and adjust or initiate antihypertensive
therapy for blood pressure control maintenance during therapy. If
increased blood pressure persists, TAVALISSE interruption,
reduction, or discontinuation may be required.
- Elevated liver function tests (LFTs), mainly ALT and AST, can
occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT
or AST increase to >3 x upper limit of normal, manage
hepatotoxicity using TAVALISSE interruption, reduction, or
discontinuation.
- Diarrhea occurred in 31% of patients and severe diarrhea
occurred in 1% of patients treated with TAVALISSE. Monitor patients
for the development of diarrhea and manage using supportive care
measures early after the onset of symptoms. If diarrhea becomes
severe (≥Grade 3), interrupt, reduce dose or discontinue
TAVALISSE.
- Neutropenia occurred in 6% of patients treated with TAVALISSE;
febrile neutropenia occurred in 1% of patients. Monitor the ANC
monthly and for infection during treatment. Manage toxicity with
TAVALISSE interruption, reduction, or discontinuation.
- TAVALISSE can cause fetal harm when administered to pregnant
women. Advise pregnant women the potential risk to a fetus. Advise
females of reproductive potential to use effective contraception
during treatment and for at least 1 month after the last dose.
Verify pregnancy status prior to initiating TAVALISSE. It is
unknown if TAVALISSE or its metabolite is present in human milk.
Because of the potential for serious adverse reactions in a
breastfed child, advise a lactating woman not to breastfeed during
TAVALISSE treatment and for at least 1 month after the last
dose.
Drug Interactions
- Concomitant use of TAVALISSE with strong CYP3A4 inhibitors
increases exposure to the major active metabolite of TAVALISSE
(R406), which may increase the risk of adverse reactions. Monitor
for toxicities that may require a reduction in TAVALISSE dose.
- It is not recommended to use TAVALISSE with strong CYP3A4
inducers, as concomitant use reduces exposure to R406.
- Concomitant use of TAVALISSE may increase concentrations of
some CYP3A4 substrate drugs and may require a dose reduction of the
CYP3A4 substrate drug.
- Concomitant use of TAVALISSE may increase concentrations of
BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp)
substrate drugs (eg, digoxin), which may require a dose reduction
of the BCRP and P-gp substrate drug.
Adverse Reactions
- Serious adverse drug reactions in the ITP double-blind studies
were febrile neutropenia, diarrhea, pneumonia, and hypertensive
crisis, which occurred in 1% of TAVALISSE patients. In addition,
severe adverse reactions occurred including dyspnea and
hypertension (both 2%), neutropenia, arthralgia, chest pain,
diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache,
syncope, and hypoxia (all 1%).
- Common adverse reactions (≥5% and more common than placebo)
from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea,
dizziness, ALT and AST increased, respiratory infection, rash,
abdominal pain, fatigue, chest pain, and neutropenia.
Please see www.TAVALISSE.com for full
Prescribing Information.
To report side effects of prescription drugs to the FDA,
visit www.fda.gov/medwatch or call 1-800-FDA-1088
(800-332-1088).
Trademarks for TAVALISSE are owned by or licensed by Rigel.
Conference Call and Webcast Today at 5:00PM Eastern Time
Rigel will hold a live
conference call and webcast today at 5:00pm
Eastern Time (2:00pm Pacific
Time).
Participants can access the live conference call by dialing
(855) 892-1489 (domestic) or (720) 634-2939 (international) and
using the Conference ID number 5189918. The slide presentation
accompanying the conference call can be accessed from Rigel's
website at www.rigel.com/webcasts. The webcast will be archived and
available for replay after the call via the Rigel website.
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), an 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 Phase
2 studies of fostamatinib in autoimmune hemolytic anemia and IgA
nephropathy. 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
U.S. commercial launch of TAVALISSE; the benefits and value to
patients of TAVALISSE; Rigel's ability to transition to an
organization prepared to launch its first commercial product;
Rigel's belief that fostamatinib may be an important alternative
for patients with ITP; and the timing and results of Rigel's
clinical trials. 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," "should," "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, risks and
uncertainties associated with the commercialization of TAVALISSE;
risks that the FDA or other regulatory authorities may make adverse
decisions regarding TAVALISSE; 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 Annual Report on Form 10-K
for the period ended December 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: ir@rigel.com
Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@syneoshealth.com
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SOURCE Rigel Pharmaceuticals, Inc.