REG - GlaxoSmithKline PLC - Xevudy approved in Europe to treat COVID-19

GSKAnnouncement

17/12/2021 12:50

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RNS Number : 0732W  GlaxoSmithKline PLC  17 December 2021

Issued: 17 December 2021, London UK and San Francisco, US

 

Xevudy (sotrovimab) granted marketing authorisation by the European Commission
for the early treatment of COVID-19

 

 

 

GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR)
today announced that the European Commission (EC) has granted marketing
authorisation 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 authorisation in the EU is a result of the positive
opinion issued on 16 December by the European Medicines Agency's Committee for
Human Medicinal Products (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 authorisation 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 authorisation we are now
able to expand access, and we are discussing with governments how we can bring
sotrovimab to more patients."

 

George Scangos, PhD, chief executive officer of Vir, said: "The grant of the
marketing authorisation 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 pre-clinical 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 authorisation in the EU is based on data from the
COMET-ICE phase III trial
(https://www.medrxiv.org/content/10.1101/2021.11.03.21265533v1) ,
demonstrating that intravenous treatment with sotrovimab resulted in a 79%
reduction (adjusted relative risk reduction) (p<0.001) in all-cause
hospitalisations 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 (https://www.biorxiv.org/content/10.1101/2021.03.09.434607v9) ,
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 neutralising 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 authorised for emergency use in the US. Xevudy (sotrovimab) has
been granted a Marketing Authorisation in the EU, conditional marketing
authorisation in Great Britain, provisional marketing authorisation in
Australia, and conditional marketing authorisation in Saudi Arabia. It has
also been approved via Japan's Special Approval for Emergency Pathway.
Temporary authorisations 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 authorisation 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 authorisation 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
(http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc)
.

 

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
embryofoetal 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 foetus. The potential treatment benefit or
risk of placental transfer of sotrovimab to the developing foetus is not
known.  Sotrovimab should be used during pregnancy only if the expected
benefit to the mother justifies the potential risk to the foetus.

 

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 U.S.C. § 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
(https://www.sotrovimab.com/content/dam/cf-pharma/hcp-sotrovimab-phase2/en_US/sotrovimab-fda-letter-of-authorization.pdf)
, full Fact Sheet for Healthcare Providers
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Sotrovimab/pdf/SOTROVIMAB-EUA.PDF#nameddest=HCPFS)
and full Fact Sheet for Patients, Parents, and Caregivers
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Sotrovimab/pdf/SOTROVIMAB-PATIENT-FACT-SHEET.PDF)
.

 

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 organisations.

 

GSK is collaborating with several organisations 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 III 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, optimised 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/about-us (https://www.gsk.com/en-gb/about-us/) .

 

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 (http://www.vir.bio/) .

 

 GSK enquiries:
 Media enquiries:             Tim Foley          +44 (0) 20 8047 5502  (London)
                              Madeleine Breckon  +44 (0) 20 8047 5502  (London)
                              Kristen Neese      +1 804 217 8147       (Philadelphia)
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 Analyst/Investor enquiries:  Nick Stone         +44 (0) 7717 618834   (London)
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                              James Dodwell      +44 (0) 20 8047 2406  (London)
                              Mick Readey        +44 (0) 7990 339653   (London)
                              Jeff McLaughlin    +1 215 751 7002       (Philadelphia)
                              Frannie DeFranco   +1 215 751 4855       (Philadelphia)

 

 

Vir Biotechnology Contacts:

Heather Rowe Armstrong                       Cara Miller

VP, Investor Relations                           VP,
Corporate Communications

harmstrong@vir.bio
cmiller@vir.bio

+1 415 915
4228                                    +1
415 941 6746

 

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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