SOUTH SAN FRANCISCO, Calif.,
Dec. 4, 2020 /PRNewswire/ -- Rigel Pharmaceuticals,
Inc. (Nasdaq: RIGL) today announced that data related to
TAVALISSE® (fostamatinib disodium hexahydrate) tablets
will be presented in two poster presentations at the
62nd American Society of Hematology (ASH) Annual Meeting
and Exposition to be held virtually December
5-8, 2020. The poster presentations will be made available
on the event's website at
https://www.hematology.org/meetings/annual-meeting on
Saturday, December 5 at 7:30am PT.
Rigel will present an analysis of long-term safety data on
fostamatinib in more than 3,500 patients at various dosing regimens
with immune thrombocytopenia (ITP) or rheumatoid arthritis
(RA). No new safety signals nor cumulative toxicity
were observed with up to 62 months (5.2 years) of continuous
treatment in ITP patients and up to 81 months (6.8 years) of
continuous treatment in RA patients.
An overview of Rigel's ongoing Phase 3 clinical trial of
fostamatinib in warm autoimmune hemolytic anemia
(wAIHA) will also be presented. This is a randomized,
double-blind, placebo-controlled study of approximately 90 patients
with primary or secondary wAIHA who have failed at least one prior
treatment. This study is based on Rigel's Phase 2,
open-label, multi-center study for the treatment of wAIHA. Results
of that study demonstrated that 44% (11/25) of patients had
markedly improved hemoglobin (Hgb) levels and adverse events were
consistent with those in the fostamatinib safety database.
Additionally, Rigel's planned Phase 3 clinical trial to evaluate
the efficacy and safety of fostamatinib in adult, hospitalized
COVID-19 patients was featured in an ASH abstract published in the
November 26, 2020, issue of
Blood. This is a multi-center, double-blind,
placebo-controlled, adaptive design study with a primary endpoint
that measures the proportion of subjects who progress to
severe/critical disease within 29 days.
Fostamatinib is commercially available in the U.S. under the
brand name TAVALISSE® (fostamatinib disodium
hexahydrate) tablets, which is the first and only spleen
tyrosine kinase (SYK) inhibitor indicated for the treatment of
thrombocytopenia in adult patients with chronic ITP who have had an
insufficient response to a previous treatment. The FDA has granted
TAVALISSE Orphan Drug designation for the treatment of patients
with warm AIHA.
Poster Presentations
Abstract
#838
Long-Term Safety Profile of the Oral Spleen Tyrosine
Kinase Inhibitor Fostamatinib in Immune Thrombocytopenia (ITP) and
Other Diseases
Presenter: Aaron Sheppard,
PhD
Session Name: 311. Disorders of Platelet Number or
Function: Poster I
Date & Time: Saturday, December 5, 2020:
7:00 AM-3:30 PM PT
Abstract #752
Fostamatinib for the Treatment of
Warm Antibody Autoimmune Hemolytic Anemia (wAIHA): A Phase 3,
Randomized, Double-Blind, Placebo-Controlled, Global
Study
Presenting Author: Nichola Cooper, MD
Session Name: 101. Red Cells and Erythropoiesis, Structure
and Function, Metabolism, and Survival, Excluding Iron: Poster
I
Date & Time: Saturday, December 5, 2020:
7:00 AM-3:30 PM PT
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 include fatigue,
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. In addition
to fostamatinib, current therapies for ITP include steroids, blood
platelet production boosters (TPO-RAs) 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 45,000 adult patients in
the U.S. and can be a severe, debilitating disease. Warm AIHA
(wAIHA), the most common form of AIHA, is characterized by the
presence of antibodies that react with the red blood cell surface
at body temperature. 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 and TAVLESSE are registered trademarks 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) 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. The
product has been approved by the European Commission for the
treatment of chronic immune thrombocytopenia in adult patients who
are refractory to other treatments and will be marketed in
Europe under the name
TAVLESSE® (fostamatinib).
Fostamatinib1 is currently being studied in a Phase 3
trial for the treatment of warm autoimmune hemolytic anemia (AIHA);
an NIH/NHLBI-Sponsored Phase 2 trial for the treatment of
hospitalized COVID-19 patients, in collaboration with Inova Health
System; and a Phase 2 trial for the treatment of COVID-19 being
conducted by Imperial College London. Additionally, Rigel plans to
launch a Phase 3 clinical trial of fostamatinib for the treatment
of hospitalized COVID-19 patients in the fourth quarter of
2020.
Rigel's other clinical programs include an ongoing Phase 1 study
of R8351, a proprietary molecule from its interleukin
receptor associated kinase (IRAK) inhibitor program, and an ongoing
Phase 1 study of R5521, a proprietary molecule from its
receptor-interacting protein kinase (RIP) inhibitor program. In
addition, Rigel has product candidates in clinical development with
partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.
1 The product for this use or indication is
investigational and has not been proven safe or effective by any
regulatory authority.
Forward Looking Statements
This release contains forward-looking statements relating to, among
other things, the safety, tolerability, design, timing and results
of Rigel's products, product candidates and 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 "potential," "may,"
"expects" 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 Annual Report on Form 10-K for the year ended
December 31, 2019 and Quarterly
Report on Form 10-Q for the quarter ended September 30, 2020. In addition, the COVID-19
pandemic may result in further delays in Rigel's studies, trials
and sales, or impact Rigel's ability to obtain supply of TAVALISSE.
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.
IR Contact: David Burke
Phone: 650.624.1232
Email: dburke@rigel.com
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SOURCE Rigel Pharmaceuticals, Inc.