SOUTH SAN FRANCISCO, Calif.,
Nov. 1, 2018 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced
that two-year safety and efficacy data from its FIT Phase 3
extension study (FIT3) for the treatment of thrombocytopenia in
adult patients with chronic immune thrombocytopenia (ITP) who have
had an insufficient response to a previous treatment has been
accepted for an oral presentation at the 60th American Society of
Hematology (ASH) Annual Meeting & Exposition to be held
December 1-4, 2018, in San Diego, CA. Additionally, data from the
open-label extension period of the SOAR Phase 2 clinical study in
patients with warm antibody autoimmune hemolytic anemia (AIHA) and
data from the exploratory analyses of the relationship between
anti-platelet antibodies in adult patients with ITP and their
response to fostamatinib1 have been accepted for
two separate poster presentations.
Fostamatinib disodium hexahydrate is an oral drug designed to
inhibit spleen tyrosine kinase (SYK), a key signaling component of
the body's immune process that is believed to lead to platelet
destruction in ITP and red blood cell destruction in AIHA.
Fostamatinib is commercially available in the U.S. under the brand
name TAVALISSE™ (fostamatinib disodium hexahydrate) tablets, which
is the first and only SYK inhibitor indicated for the treatment of
thrombocytopenia in adult patients with chronic ITP who have had an
insufficient response to a previous treatment.
Fostamatinib1 is currently being investigated in AIHA, a
rare, serious blood disorder in which the immune system produces
antibodies that result in the destruction of the body's own red
blood cells, and for which there are no approved therapies.
Oral Presentation
Abstract #736
Two-Year
Safety and Efficacy Outcomes with Fostamatinib in Adult Patients
with Immune Thrombocytopenia (ITP): Open-Label Extension to Phase 3
Trial Program
Session Name: 311. Disorders of Platelet
Number or Function: Advances in the Treatment of ITP
Presenter: Anne-Marie Duliege, MD, Executive Vice President and
Chief Medical Officer
Date: Monday, December 3, 2018
Presentation Time: 3:30 PM PST
Location: San Diego Convention
Center, Room 31B
Poster Presentations
Abstract
#3612
Fostamatinib1, a Spleen Tyrosine Kinase
Inhibitor, for the Treatment of Warm Antibody Autoimmune Hemolytic
Anemia: Initial Results of the Multicenter, Open-Label Extension
Period of the SOAR Phase 2 Study
Session Name: 101. Red
Cells and Erythropoiesis, Structure and Function, Metabolism, and
Survival, Excluding Iron: Poster III
Date: Monday, December 3, 2018
Presentation Time: 6:00 PM - 8:00 PM
PST
Location: San Diego Convention
Center, Hall GH
Abstract #3766
Prediction of Response to
Fostamatinib based on the Presence of Plasma Platelet
Autoantibodies in Adult Patients with Immune Thrombocytopenia (ITP)
– Exploratory Analyses from Phase 3 Studies
Session
Name: 311. Disorders of Platelet Number or Function: Poster
III
Date: Monday, December 3, 2018
Presentation Time: 6:00 PM - 8:00 PM
PST
Location: San Diego Convention
Center, Hall GH
The conference abstracts can be accessed here.
To learn more about Rigel Pharmaceuticals and
TAVALISSE™ visit booth #1449 during ASH 2018.
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 (TPOs) and splenectomy. However, not
all patients respond to existing therapies. As a result, there
remains a significant medical need for additional treatment options
for patients with ITP.
About AIHA
Autoimmune hemolytic anemia (AIHA) is a
rare, serious blood disorder in which the immune system produces
antibodies that result in the destruction of the body's own red
blood cells. AIHA affects approximately 40,000 adult patients in
the US and can be a severe, debilitating disease. To date, there
are no disease-targeted therapies approved for AIHA, despite the
unmet medical need that exists for these patients.
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).
TAVALISSE is a trademark of Rigel Pharmaceuticals,
Inc.
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 clinical programs include an upcoming
Phase 3 study of fostamatinib1 in autoimmune hemolytic
anemia and an ongoing Phase 1 study of R8351, a
proprietary molecule from its interleukin receptor associated
kinase (IRAK) program. In addition, Rigel has product candidates in
development with partners BerGenBio AS, Daiichi Sankyo, and Aclaris
Therapeutics.
1 The product for this use or indication is
investigational and has not been proven safe or effective by any
regulatory authority.
Contact: David Burke
Phone: 650.624.1232
Email: dburke@rigel.com
Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@syneoshealth.com
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SOURCE Rigel Pharmaceuticals, Inc.