GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc.
(Nasdaq: VIR) today announced that the European Commission (EC) has
granted marketing authorization to Xevudy (sotrovimab) for the
early treatment of COVID-19. Sotrovimab is now approved in the
European Union (EU) for the treatment of adults and adolescents
(aged 12 years and over and weighing at least 40kg) with COVID-19
who do not require supplemental oxygen and who are at increased
risk of progressing to severe COVID-19.
The grant of the marketing authorization in the
EU is a result of the positive opinion issued on December 16 by the
European Medicines Agency’s Committee for Medicinal Products for
Human Use (CHMP).
In July 2021, GSK and Vir announced a Joint
Procurement Agreement (JPA) with the EC to supply up to 220,000
doses of sotrovimab. Following the grant of the marketing
authorization in the EU, Member States participating in the JPA can
now order sotrovimab to support their pandemic responses.
Dr Hal Barron, Chief Scientific Officer
and President R&D, GSK, said: “Since the start of the
pandemic we have seen an unprecedented effort by governments,
academia and industry to find solutions to help as many people as
quickly as possible. COVID-19 therapeutics are an important part of
the solution. We have already been working to lay the foundation
for more patients across Europe to access sotrovimab through the
Joint Procurement Agreement with the European Commission. With
today’s marketing authorization we are now able to expand access,
and we are discussing with governments how we can bring sotrovimab
to more patients.”
George
Scangos, Ph.D., Chief Executive
Officer of
Vir, said: “The grant of the
marketing authorization in the European Union for sotrovimab marks
yet another important milestone in our efforts to combat COVID-19,
as it allows us to expand access across multiple countries working
to address this challenge. Given recent preclinical data from our
own labs, as well as that of other independent labs, demonstrating
that sotrovimab retains activity against the rapidly spreading
Omicron variant and all other currently tested variants of concern
and interest, we remain confident in the critical role of
sotrovimab and look forward to further contributing to the fight
against this pandemic.”
The grant of the marketing authorization in the
EU is based on data from the COMET-ICE Phase 3 trial, demonstrating
that intravenous treatment with sotrovimab resulted in a 79%
reduction (adjusted relative risk reduction) (p<0.001) in
all-cause hospitalizations for more than 24 hours or death due to
any cause by Day 29 compared to placebo, meeting the primary
endpoint of the trial. In absolute numbers, 30 (6%) of the 529
patients in the placebo arm progressed, compared to six (1%) of the
528 patients receiving sotrovimab. In clinical trials conducted to
date, sotrovimab has been well-tolerated. The most common adverse
reactions are hypersensitivity and infusion-related reactions, seen
in approximately 2% and 1% of cases, respectively.
GSK and Vir are committed to the ongoing
evaluation of sotrovimab as the COVID-19 landscape continues to
evolve at different rates across the globe and new variants of
concern and interest emerge. Updated in vitro data, published in
bioRxiv, demonstrate that sotrovimab retains activity against all
tested variants of concern and interest of the SARS-CoV-2 virus as
defined by the World Health Organization, including, but not
limited to, Omicron (B.1.1.529), Delta (B.1.617.2), Delta Plus
(AY.1 or AY.2) and Mu (B.1.621).
About Xevudy
(Sotrovimab)Xevudy
(sotrovimab) is an investigational SARS-CoV-2 neutralizing
monoclonal antibody. The antibody binds to an epitope on SARS-CoV-2
shared with SARS-CoV-1 (the virus that causes SARS), indicating
that the epitope is highly conserved, which may make it more
difficult for resistance to develop. Sotrovimab, which incorporates
Xencor, Inc.’s Xtend™ technology, has also been designed to achieve
high concentration in the lungs to ensure optimal penetration into
airway tissues affected by SARS-CoV-2 and to have an extended
half-life.
About Global
Access to
Sotrovimab
Sotrovimab is authorized for emergency use in
the US. Xevudy (sotrovimab) has been granted a Marketing
Authorization in the EU, conditional marketing authorization in
Great Britain, provisional marketing authorization in Australia,
and conditional marketing authorization in Saudi Arabia. It has
also been approved via Japan’s Special Approval for Emergency
Pathway. Temporary authorizations for sotrovimab have been granted
in 12 other countries.
Sotrovimab is supplied in several countries
worldwide, including through national agreements in the US, UK,
Japan, Australia, Canada, Singapore, Switzerland and the United
Arab Emirates. The companies have also announced a JPA with the EC
to supply doses of sotrovimab to participating Member States of the
EU. Additional agreements are yet to be disclosed due to
confidentiality or regulatory requirements.
Important Information
About Sotrovimab in the European
Union
For more information on the marketing
authorization in the European Union, please review the Summary of
Product Characteristics (SmPC). Healthcare professionals should
look out for side effects and take appropriate action.
Reporting of Suspected
Adverse Reactions
Reporting suspected adverse reactions after
authorization of the medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected
adverse reactions via the national reporting system listed in
Appendix V.
Warnings and
Precautions
Hypersensitivity
Reactions including
Anaphylaxis
Hypersensitivity reactions, including
anaphylaxis, have been reported with administration of sotrovimab
(see section 4.8 of the SmPC). If signs or symptoms of a clinically
significant hypersensitivity reaction or anaphylaxis occur,
administration should be discontinued immediately and appropriate
medications and/or supportive care should be given.
Infusion-Related
Reactions
Infusion-related reactions (IRRs) have been
observed with intravenous administration of monoclonal antibodies
(see section 4.8 of the SmPC). These reactions may be severe or
life-threatening. If an IRR occurs, the infusion may be
interrupted, slowed or stopped.
Adverse
Reactions
The most common adverse reactions were
hypersensitivity reactions (2%) and infusion-related reactions
(1%). The most serious adverse reaction was anaphylaxis
(0.05%).
Pregnancy
There are no data from the use of sotrovimab in
pregnant women. Animal studies have not been evaluated with respect
to reproductive toxicity. In a cross-reactive binding assay using a
protein array enriched for human embryofetal proteins, no
off-target binding was detected. Since sotrovimab is a human
immunoglobulin G (IgG), it has the potential for placental transfer
from the mother to the developing fetus. The potential treatment
benefit or risk of placental transfer of sotrovimab to the
developing fetus is not known. Sotrovimab should be used
during pregnancy only if the expected benefit to the mother
justifies the potential risk to the fetus.
Lactation
It is not known whether sotrovimab is excreted
in human milk or absorbed systemically after ingestion.
Administration of sotrovimab while breast-feeding can be considered
when clinically indicated.
Sotrovimab in the United
States
The following is a summary of information for
sotrovimab. Healthcare providers in the US should review the Fact
Sheets for information about the authorized use of sotrovimab and
mandatory requirements of the Emergency Use Authorization (EUA).
Sotrovimab has been authorized by the US FDA for the emergency use
described below. Sotrovimab is not FDA-approved for this use.
Sotrovimab is authorized only for the duration
of the declaration that circumstances exist justifying the
authorization of the emergency use of sotrovimab under section
564(b)(1) of the Act, 21 USC § 360bbb-3(b)(1), unless the
authorization is terminated or revoked sooner.
Authorized Use
The US FDA has issued an EUA to permit the
emergency use of the unapproved product sotrovimab for the
treatment of mild-to-moderate coronavirus disease 2019 (COVID-19)
in adults and pediatric patients (12 years of age and older
weighing at least 40kg) with positive results of direct SARS-CoV-2
viral testing, and who are at high risk for progression to severe
COVID-19, including hospitalization or death.
Limitations of Authorized
Use
Sotrovimab is not authorized for use in
patients:
- who are hospitalized due to
COVID-19, OR
- who require oxygen therapy due to
COVID-19, OR
- who require an increase in baseline
oxygen flow rate due to COVID-19 (in those on chronic oxygen
therapy due to underlying non-COVID-19 related comorbidity)
Benefit of treatment with sotrovimab has not
been observed in patients hospitalized due to COVID19. SARS-CoV-2
monoclonal antibodies may be associated with worse clinical
outcomes when administered to hospitalized patients with COVID19
requiring high flow oxygen or mechanical ventilation.
Please see the Food and Drug Administration
(FDA) Letter of Authorization, full Fact Sheet for Healthcare
Providers and full Fact Sheet for Patients, Parents, and
Caregivers.
About the GSK and Vir
Collaboration
In April 2020, GSK and Vir entered into a
collaboration to research and develop solutions for coronaviruses,
including SARS-CoV-2, the virus that causes COVID-19. The
collaboration uses Vir’s proprietary monoclonal antibody platform
technology to accelerate existing and identify new anti-viral
antibodies that could be used as therapeutic or preventive options
to help address the current COVID-19 pandemic and future outbreaks.
The companies will leverage GSK’s expertise in functional genomics
and combine their capabilities in CRISPR screening and artificial
intelligence to identify anti-coronavirus compounds that target
cellular host genes. They will also apply their combined expertise
to research SARS-CoV-2 and other coronavirus vaccines.
GSK
Commitment to
Tackling COVID-19
GSK’s response to COVID-19 has been one of the
broadest in the industry, with potential treatments in addition to
the Company’s vaccine candidates in development with partner
organizations.
GSK is collaborating with several organizations
on COVID-19 vaccines by providing access to its adjuvant
technology. The Company is working with Sanofi SA, Medicago Inc.
and SK bioscience Co., Ltd. to develop adjuvanted, protein-based
vaccine candidates, and all are now in Phase 3 clinical trials. The
use of an adjuvant can be of particular importance in a pandemic
since it may reduce the amount of vaccine protein required per
dose, allowing more vaccine doses to be produced and contributing
to protecting more people in need.
GSK is also working with mRNA specialist CureVac
NV to jointly develop next-generation, optimized mRNA vaccines for
COVID-19 with the potential to address multiple emerging variants
in one vaccine.
GSK is also exploring treatments for COVID-19
patients, collaborating with Vir Biotechnology to investigate
monoclonal antibodies that could be used as therapeutic or
preventive options for COVID-19.
Vir’s
Commitment to COVID-19
Vir was founded with the mission of addressing
the world’s most serious infectious diseases. In 2020, Vir
responded rapidly to the COVID-19 pandemic by leveraging our unique
scientific insights and industry-leading antibody platform to
explore multiple monoclonal antibodies as potential therapeutic or
preventive options for COVID-19. Sotrovimab is the first
SARS-CoV-2-targeting antibody Vir advanced into the clinic. It was
carefully selected for its demonstrated promise in preclinical
research, including an anticipated high barrier to resistance and
potential ability to both block the virus from entering healthy
cells and clear infected cells. Vir is continuing to pursue novel
therapeutic and prophylactic solutions to combat SARS-CoV-2 and
future coronavirus pandemics, both independently and in
collaboration with its partners.
About GSK
GSK is a science-led global healthcare company.
For further information please visit www.gsk.com/aboutus.
About Vir Biotechnology
Vir Biotechnology is a commercial-stage
immunology company focused on combining immunologic insights with
cutting-edge technologies to treat and prevent serious infectious
diseases. Vir has assembled four technology platforms that are
designed to stimulate and enhance the immune system by exploiting
critical observations of natural immune processes. Its current
development pipeline consists of product candidates targeting
COVID-19, hepatitis B virus, influenza A and human immunodeficiency
virus. For more information, please visit www.vir.bio.
GSK Cautionary Statement Regarding
Forward-Looking Statements
GSK cautions investors that any forward-looking
statements or projections made by GSK, including those made in this
announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Such
factors include, but are not limited to, those described in the
Company's Annual Report on Form 20-F for 2020, GSK’s 2021 Q3
Results and any impacts of the COVID-19 pandemic.
Vir Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as “may,” “will,” “plan,”
“potential,” “aim,” “promising” and similar expressions (as well as
other words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
These forward-looking statements are based on Vir’s expectations
and assumptions as of the date of this press release.
Forward-looking statements contained in this press release include,
but are not limited to, statements regarding the ability of
sotrovimab to treat and/or prevent COVID-19 either through IV or IM
administration, Vir’s collaboration with GSK, plans to progress
regulatory submissions globally, including with the FDA regarding
the existing EUA for sotrovimab, planned discussions with other
global regulatory agencies, the timing of availability of clinical
data, program updates and data disclosures, the clinical
development program for sotrovimab, and the ability of sotrovimab
to maintain activity against circulating variants of concern and
interest, including Omicron. Many factors may cause differences
between current expectations and actual results, including
unexpected safety or efficacy data observed during preclinical or
clinical studies, challenges in the treatment of hospitalized
patients, difficulties in collaborating with other companies or
government agencies, challenges in accessing manufacturing
capacity, successful development and/or commercialization of
alternative product candidates by Vir’s competitors, changes in
expected or existing competition, delays in or disruptions to Vir’s
business or clinical trials due to the COVID-19 pandemic,
geopolitical changes or other external factors, and unexpected
litigation or other disputes. Other factors that may cause actual
results to differ from those expressed or implied in the
forward-looking statements in this press release are discussed in
Vir’s filings with the U.S. Securities and Exchange Commission,
including the section titled “Risk Factors” contained therein.
Except as required by law, Vir assumes no obligation to update any
forward-looking statements contained herein to reflect any change
in expectations, even as new information becomes available.
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