SOUTH SAN FRANCISCO,
June 13, 2019 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced
that it will present data on fostamatinib disodium hexahydrate
(fostamatinib) in two posters at the 24th Congress of
the European Hematology Association (EHA) in Amsterdam, The Netherlands, on June 13-16, 2019. Data presented will
overview long-term safety and efficacy of fostamatinib from the 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. Additionally, Rigel will highlight data from
its open-label extension period of the SOAR Phase 2 clinical study
in patients with warm antibody autoimmune hemolytic anemia (AIHA).
The abstracts are available on the EHA website at
www.ehaweb.org/congress.
Fostamatinib 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), 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 a Phase 3 registrational trial in AIHA, a rare, serious blood
disorder in which the immune system produces antibodies that result
in the destruction of the body's own healthy red blood cells and
for which there are currently no approved therapies.
Poster Presentations
Abstract
#PF703
Title: Long-term Fostamatinib Treatment of Adults
with Immune Thrombocytopenia (ITP) During the Phase 3 Clinical
Trial Program
Session Title: Platelets disorders
Date: Friday, June 14
Presentation Time: 5:30 - 7:00 PM
CEST
Location: RAI Amsterdam – Amsterdam,
Netherlands
Abstract # PF427
Title: Fostamatinib, a Spleen
Tyrosine Kinase Inhibitor, for the Treatment of Warm Antibody
Autoimmune Hemolytic Anemia: Initial Results of the Open-Label
Extension Period of the SOAR Phase 2 Study
Session Title:
Enzymopathies, membranopathies and other anemias
Date: Friday, June 14
Presentation Time: 5:30 - 7:00 PM
CEST
Location: RAI Amsterdam – Amsterdam,
Netherlands
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 are
adequately treated with existing therapies. As a result, there
remains a significant medical need for additional treatment options
for patients with ITP.
About AIHA
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 U.S. 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 (e.g., rosuvastatin) and P-Glycoprotein (P-gp)
substrate drugs (e.g., 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 registered 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), 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 clinical
programs include a Phase 3 study of TAVALISSE in warm autoimmune
hemolytic anemia (AIHA) and a 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.
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
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SOURCE Rigel Pharmaceuticals, Inc.