TG Therapeutics, Inc. (NASDAQ: TGTX), today announced
that the European Commission (EC) has granted approval of BRIUMVI®
(ublituximab-xiiy) for the treatment of adult patients with
relapsing forms of multiple sclerosis (RMS) with active disease
defined by clinical or imaging features.
BRIUMVI was granted approval by the U.S. Food and Drug
Administration on December 28, 2022, for the treatment of RMS in
adults. BRIUMVI is the first and only anti-CD20 monoclonal antibody
approved in the U.S. and now the European Union (EU) for adult
patients with RMS that can be administered in a one-hour infusion
following the starting dose.
Michael S. Weiss, the Company's Chairman and Chief Executive
Officer, stated, "We are very pleased that the European Commission
has approved BRIUMVI for the treatment of adult patients with
multiple sclerosis. This brings us one step closer to our goal of
providing MS patients in Europe with an alternative treatment
option that can be delivered in a one-hour infusion every 6 months
following the starting dose and we are targeting commercial
availability later this year.”
The EC approval is based on data from the ULTIMATE I & II
Phase 3 trials, which demonstrated superiority over teriflunomide
in significantly reducing the annualized relapse rate (ARR, the
primary endpoint), the number of T1 Gd-enhancing lesions and the
number of new or enlarging T2 lesions. Results from the ULTIMATE I
& II trials were published in August 2022 in The New
England Journal of Medicine.
With this approval, the centralised marketing
authorisation is now valid in all European Union (EU) Member
States, Iceland, Norway and Liechtenstein.
ABOUT THE ULTIMATE I & II PHASE 3
TRIALSULTIMATE I & II are two randomized,
double-blind, double-dummy, parallel group, active
comparator-controlled clinical trials of identical design, in
patients with RMS treated for 96 weeks. Patients were randomized to
receive either BRIUMVI, given as an IV infusion of 150 mg
administered in four hours, 450 mg two weeks after the first
infusion administered in one hour, and 450 mg every 24 weeks
administered in one hour, with oral placebo administered daily; or
teriflunomide, the active comparator, given orally as a 14 mg daily
dose with IV placebo administered on the same schedule as BRIUMVI.
Both studies enrolled patients who had experienced at least one
relapse in the previous year, two relapses in the previous two
years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion
in the previous year. Patients were also required to have an
Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at
baseline. The ULTIMATE I & II trials enrolled a total of 1,094
patients with RMS across 10 countries. These trials were led by
Lawrence Steinman, MD, Zimmermann Professor of Neurology &
Neurological Sciences, and Pediatrics at Stanford University.
Additional information on these clinical trials can be found at
www.clinicaltrials.gov (NCT03277261; NCT03277248).
ABOUT BRIUMVI™ (ublituximab-xiiy) 150 mg/6 mL Injection
for IVBRIUMVI is a novel monoclonal antibody that targets
a unique epitope on CD20-expressing B-cells. Targeting CD20 using
monoclonal antibodies has proven to be an important therapeutic
approach for the management of autoimmune disorders, such as RMS.
BRIUMVI is uniquely designed to lack certain sugar molecules
normally expressed on the antibody. Removal of these sugar
molecules, a process called glycoengineering, allows for efficient
B-cell depletion at low doses.
BRIUMVI is indicated for the treatment of adults with relapsing
forms of multiple sclerosis (RMS), to include clinically isolated
syndrome, relapsing-remitting disease, and active secondary
progressive disease.
A list of authorized specialty distributors can be found at
www.briumvi.com.
IMPORTANT SAFETY
INFORMATIONContraindications: BRIUMVI is
contraindicated in patients with:
- Active HBV infection
- A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS
Infusion Reactions: BRIUMVI can cause infusion
reactions, which can include pyrexia, chills, headache,
influenza-like illness, tachycardia, nausea, throat irritation,
erythema, and an anaphylactic reaction. In MS clinical trials, the
incidence of infusion reactions in BRIUMVI-treated patients who
received infusion reaction-limiting premedication prior to each
infusion was 48%, with the highest incidence within 24 hours of the
first infusion. 0.6% of BRIUMVI-treated patients experienced
infusion reactions that were serious, some requiring
hospitalization.
Observe treated patients for infusion reactions during the
infusion and for at least one hour after the completion of the
first two infusions unless infusion reaction and/or
hypersensitivity has been observed in association with the current
or any prior infusion. Inform patients that infusion reactions can
occur up to 24 hours after the infusion. Administer the recommended
pre-medication to reduce the frequency and severity of infusion
reactions. If life-threatening, stop the infusion immediately,
permanently discontinue BRIUMVI, and administer appropriate
supportive treatment. Less severe infusion reactions may involve
temporarily stopping the infusion, reducing the infusion rate,
and/or administering symptomatic treatment.
Infections: Serious, life-threatening or fatal,
bacterial and viral infections have been reported in
BRIUMVI-treated patients. In MS clinical trials, the overall rate
of infections in BRIUMVI-treated patients was 56% compared to 54%
in teriflunomide-treated patients. The rate of serious infections
was 5% compared to 3% respectively. There were 3 infection-related
deaths in BRIUMVI-treated patients. The most common infections in
BRIUMVI-treated patients included upper respiratory tract infection
(45%) and urinary tract infection (10%). Delay BRIUMVI
administration in patients with an active infection until the
infection is resolved.
Consider the potential for increased immunosuppressive effects
when initiating BRIUMVI after immunosuppressive therapy or
initiating an immunosuppressive therapy after BRIUMVI.
Hepatitis B Virus (HBV) Reactivation: HBV
reactivation occurred in an MS patient treated with BRIUMVI in
clinical trials. Fulminant hepatitis, hepatic failure, and death
caused by HBV reactivation have occurred in patients treated with
anti-CD20 antibodies. Perform HBV screening in all patients before
initiation of treatment with BRIUMVI. Do not start treatment with
BRIUMVI in patients with active HBV confirmed by positive results
for HBsAg and anti-HB tests. For patients who are negative for
surface antigen [HBsAg] and positive for HB core antibody [HBcAb+]
or are carriers of HBV [HBsAg+], consult a liver disease expert
before starting and during treatment.
Progressive Multifocal Leukoencephalopathy
(PML): Although no cases of PML have occurred in
BRIUMVI-treated MS patients, JCV infection resulting in PML has
been observed in patients treated with other anti-CD20 antibodies
and other MS therapies.
If PML is suspected, withhold BRIUMVI and perform an appropriate
diagnostic evaluation. Typical symptoms associated with PML are
diverse, progress over days to weeks, and include progressive
weakness on one side of the body or clumsiness of limbs,
disturbance of vision, and changes in thinking, memory, and
orientation leading to confusion and personality changes.
MRI findings may be apparent before clinical signs or symptoms;
monitoring for signs consistent with PML may be useful. Further
investigate suspicious findings to allow for an early diagnosis of
PML, if present. Following discontinuation of another MS medication
associated with PML, lower PML-related mortality and morbidity have
been reported in patients who were initially asymptomatic at
diagnosis compared to patients who had characteristic clinical
signs and symptoms at diagnosis.
If PML is confirmed, treatment with BRIUMVI should be
discontinued.
Vaccinations: Administer all immunizations
according to immunization guidelines: for live or live-attenuated
vaccines at least 4 weeks and, whenever possible at least 2 weeks
prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may
interfere with the effectiveness of non-live vaccines. The safety
of immunization with live or live-attenuated vaccines during or
following administration of BRIUMVI has not been studied.
Vaccination with live virus vaccines is not recommended during
treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers Treated with
BRIUMVI During Pregnancy: In infants of mothers exposed to
BRIUMVI during pregnancy, assess B-cell counts prior to
administration of live or live-attenuated vaccines as measured by
CD19+ B-cells. Depletion of B-cells in these infants may increase
the risks from live or live-attenuated vaccines. Inactivated or
non-live vaccines may be administered prior to B-cell recovery.
Assessment of vaccine immune responses, including consultation with
a qualified specialist, should be considered to determine whether a
protective immune response was mounted.
Fetal Risk: Based on data from animal studies,
BRIUMVI may cause fetal harm when administered to a pregnant woman.
Transient peripheral B-cell depletion and lymphocytopenia have been
reported in infants born to mothers exposed to other anti-CD20
B-cell depleting antibodies during pregnancy. A pregnancy test is
recommended in females of reproductive potential prior to each
infusion. Advise females of reproductive potential to use effective
contraception during BRIUMVI treatment and for 6 months after the
last dose.
Reduction in Immunoglobulins: As expected with
any B-cell depleting therapy, decreased immunoglobulin levels were
observed. Decrease in immunoglobulin M (IgM) was reported in 0.6%
of BRIUMVI-treated patients compared to none of the patients
treated with teriflunomide in RMS clinical trials. Monitor the
levels of quantitative serum immunoglobulins during treatment,
especially in patients with opportunistic or recurrent infections,
and after discontinuation of therapy until B-cell repletion.
Consider discontinuing BRIUMVI therapy if a patient with low
immunoglobulins develops a serious opportunistic infection or
recurrent infections, or if prolonged hypogammaglobulinemia
requires treatment with intravenous immunoglobulins.
Most Common Adverse Reactions: The most common
adverse reactions in RMS trials (incidence of at least 10%) were
infusion reactions and upper respiratory tract infections.
Physicians, pharmacists, or other healthcare professionals with
questions about BRIUMVI should visit www.briumvi.com.
ABOUT BRIUMVI PATIENT SUPPORT BRIUMVI Patient
Support is a flexible program designed by TG
Therapeutics to support patients through their treatment
journey in a way that works best for them. More information about
the BRIUMVI Patient Support program can be accessed at
www.briumvipatientsupport.com.
ABOUT MULTIPLE SCLEROSIS Relapsing multiple
sclerosis (RMS) is a chronic demyelinating disease of the central
nervous system (CNS) and includes people with relapsing-remitting
multiple sclerosis (RRMS) and people with secondary progressive
multiple sclerosis (SPMS) who continue to experience relapses. RRMS
is the most common form of multiple sclerosis (MS) and is
characterized by episodes of new or worsening signs or symptoms
(relapses) followed by periods of recovery. It is estimated that
nearly 1 million people are living with MS in the United States and
approximately 85% are initially diagnosed with RRMS.1,2 The
majority of people who are diagnosed with RRMS will eventually
transition to SPMS, in which they experience steadily worsening
disability over time. Worldwide, more than 2.3 million people have
a diagnosis of MS.1
ABOUT TG THERAPEUTICSTG Therapeutics is a
fully integrated, commercial stage, biopharmaceutical company
focused on the acquisition, development and commercialization of
novel treatments for B-cell diseases. In addition to a research
pipeline including several investigational medicines, TG has
received approval from the U.S. FDA for BRIUMVI™
(ublituximab-xiiy), for the treatment of adult patients with
relapsing forms of multiple sclerosis, to include clinically
isolated syndrome, relapsing-remitting disease, and active
secondary progressive disease. For more information,
visit www.tgtherapeutics.com, and follow us on
Twitter @TGTherapeutics and on LinkedIn.
Cautionary StatementThis press release contains
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995.
Any forward-looking statements in this press release are based
on management's current expectations and beliefs and are subject to
a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release. In addition to the risk factors identified from
time to time in our reports filed with the U.S. Securities and
Exchange Commission (SEC), factors that could cause our actual
results to differ materially include the below.
Such forward looking statements include but are not limited to
statements regarding the results of the ULTIMATE I & II Phase 3
studies and BRIUMVI as a treatment for relapsing forms of Multiple
Sclerosis (RMS). Additional factors that could cause our actual
results to differ materially include the following: the risk that
the data from the ULTIMATE I & II trials that we announce or
publish may change, or the product profile of BRIUMVI may be
impacted, as more data or additional endpoints are analyzed; the
risk that data may emerge from future clinical studies or from
adverse event reporting that may affect the safety and tolerability
profile and commercial potential of BRIUMVI; the risk that any
individual patient’s clinical experience in the post-marketing
setting, or the aggregate patient experience in the post-marketing
setting, may differ from that demonstrated in controlled clinical
trials such as ULTIMATE I and II; the risk that BRIUMVI will not be
commercially successful in the US or ex US; our ability to expand
our commercial infrastructure, and successfully market and sell
BRIUMVI in RMS, specifically in the EU where the Company currently
does not have a commercial presence and where a commercialization
partner has not yet been identified; the Company’s reliance on
third parties for manufacturing, distribution and supply, and a
range of other support functions for our commercial and clinical
products, including BRIUMVI, and the ability of the Company and its
manufacturers and suppliers to produce and deliver BRIUMVI to meet
the market demand for BRIUMVI; the failure to obtain and maintain
requisite regulatory approvals, including in the EU, and including
the risk that the Company fails to satisfy post-approval regulatory
requirements; the uncertainties inherent in research and
development; and general political, economic and business
conditions, including the risk that the ongoing COVID-19 pandemic
could have on the safety profile of BRIUMVI and any of our other
drug candidates as well as any government control measures
associated with COVID-19 that could have an adverse impact on our
research and development plans or commercialization efforts.
Further discussion about these and other risks and uncertainties
can be found in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2022 and in our other filings with
the U.S. Securities and Exchange Commission.
Any forward-looking statements set forth in this press release
speak only as of the date of this press release. We do not
undertake to update any of these forward-looking statements to
reflect events or circumstances that occur after the date hereof.
This press release and prior releases are available
at www.tgtherapeutics.com. The information found on our
website is not incorporated by reference into this press release
and is included for reference purposes only.
CONTACT:
Investor RelationsEmail:
ir@tgtxinc.comTelephone: 1.877.575.TGTX (8489), Option 4
Media Relations: Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6
1. MS Prevalence. National Multiple
Sclerosis Society
website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence.
Accessed October 26, 2020.2. Multiple
Sclerosis International Federation, 2013 via Datamonitor p.
236.
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