GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc.
(Nasdaq: VIR) today announced that the US Food and Drug
Administration has amended the Emergency Use Authorization (EUA)
Fact Sheet for sotrovimab, an investigational monoclonal antibody.
The FDA has determined that, based on the totality of available
evidence, including new live virus data generated by Vir, it is
unlikely that the sotrovimab 500 mg dose will be effective against
the Omicron BA.2 variant. GSK and Vir are preparing a package of
data in support of a higher dose of sotrovimab for the Omicron BA.2
subvariant and will be sharing these data with regulatory and
health authorities around the world for discussion.
The FDA has updated its website to exclude
sotrovimab use in geographic regions where infection is likely to
have been caused by a non-susceptible SARS-CoV-2 variant based on
available information, including variant susceptibility to these
drugs and regional variant frequency (HHS regions 1 and 2). The FDA
will continue to monitor the prevalence of circulating variants and
update its website accordingly.
In connection with this announcement, Vir has filed a Current
Report on Form 8-K, which can be found at www.sec.gov.
About sotrovimabSotrovimab 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
sotrovimabSotrovimab is authorized for emergency use in
the United States and has been granted a marketing authorization in
the European Union (EU), conditional marketing authorization in the
UK, 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 also been granted in
several 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. Vir and GlaxoSmithKline are also supplying
sotrovimab to participating Member States of the EU through a Joint
Procurement Agreement with the European Commission. Additional
agreements are yet to be disclosed due to confidentiality or
regulatory requirements.
Sotrovimab in the United
StatesThe 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).
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.
Sotrovimab has been authorized by the 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 Food, Drug, and Cosmetic Act, 21 U.S.C. §
360bbb-3(b)(1), unless the authorization is terminated or revoked
sooner.
Authorized useThe 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
treatment of mild to moderate COVID-19 in geographic regions where
infection is likely to have been caused by a non-susceptible
SARS-CoV-2 variant based on available information including variant
susceptibility to these drugs and regional variant frequency.
- FDA’s determination and any updates
will be available at:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs.
Sotrovimab is not authorized for use in adult or
pediatric patients who:
- are hospitalized due to COVID-19,
OR
- require oxygen therapy and/or
respiratory support due to COVID-19, OR
- require an increase in baseline
oxygen flow rate and/or respiratory support due to COVID-19 in
those on chronic oxygen.
Benefit of treatment with sotrovimab has not
been observed in patients hospitalized due to COVID-19. SARS-CoV-2
monoclonal antibodies may be associated with worse clinical
outcomes when administered to hospitalized patients with COVID-19
requiring high flow oxygen or mechanical ventilation.
Important Safety
Information
CONTRAINDICATIONSSotrovimab is
contraindicated in patients who have a history of anaphylaxis to
sotrovimab or to any of the excipients in the formulation.
WARNINGS AND PRECAUTIONSThere
are limited clinical data available for sotrovimab. Serious and
unexpected adverse events may occur that have not been previously
reported with sotrovimab use.
Hypersensitivity Including Anaphylaxis
and Infusion-Related ReactionsSerious hypersensitivity
reactions, including anaphylaxis, have been observed with
administration of sotrovimab. If signs and symptoms of a clinically
significant hypersensitivity reaction or anaphylaxis occur,
immediately discontinue administration and initiate appropriate
medications and/or supportive care.
Infusion-related reactions, occurring during the
infusion and up to 24 hours after the infusion, have been observed
with administration of sotrovimab. These reactions may be severe or
life-threatening.
Signs and symptoms of infusion-related reactions
may include: fever, difficulty breathing, reduced oxygen
saturation, chills, fatigue, arrhythmia (eg, atrial fibrillation,
sinus tachycardia, bradycardia), chest pain or discomfort,
weakness, altered mental status, nausea, headache, bronchospasm,
hypotension, hypertension, angioedema, throat irritation, rash
including urticaria, pruritus, myalgia, vaso-vagal reactions (e.g.,
pre-syncope, syncope), dizziness and diaphoresis.
If an infusion-related reaction occurs, consider
slowing or stopping the infusion and administer appropriate
medications and/or supportive care. Clinically monitor patients for
at least 1 hour after completion of the infusion for signs and
symptoms of hypersensitivity. Hypersensitivity reactions occurring
more than 24 hours after the infusion have also been reported with
the use of SARS-CoV-2 monoclonal antibodies under Emergency Use
Authorization.
Clinical Worsening After SARS-CoV-2
Monoclonal Antibody AdministrationClinical worsening of
COVID‑19 after administration of SARS-CoV-2 monoclonal antibody
treatment has been reported and may include signs or symptoms of
fever, hypoxia or increased respiratory difficulty, arrhythmia
(e.g., atrial fibrillation, tachycardia, bradycardia), fatigue and
altered mental status. Some of these events required
hospitalization. It is not known if these events were related to
SARS-CoV-2 monoclonal antibody use or were due to progression of
COVID‑19.
Limitations of Benefit and Potential for
Risk in Patients with Severe
COVID‑19Benefit of
treatment with sotrovimab has not been observed in patients
hospitalized due to COVID‑19. SARS-CoV-2 monoclonal antibodies may
be associated with worse clinical outcomes when administered to
hospitalized patients with COVID‑19 requiring high flow oxygen or
mechanical ventilation. Therefore, 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.
ADVERSE EVENTSInfusion-related
reactions, including immediate hypersensitivity reactions, were
observed in subjects treated with sotrovimab in COMET-ICE (1%) and
in COMET-TAIL (<1%). Events reported within 24 hours of study
treatment were pyrexia, chills, dizziness, dyspnea, pruritus, rash,
and infusion-related reactions; all events were Grade 1 (mild) or
Grade 2 (moderate).
Hypersensitivity adverse reactions were observed
in 2% of patients treated with sotrovimab in COMET-ICE and in
<1% of subjects treated with sotrovimab in COMET-TAIL. All were
Grade 1 (mild) or Grade 2 (moderate). One reaction led to temporary
pausing of the infusion.
The most common treatment-emergent adverse
events observed in the sotrovimab treatment group in COMET-ICE were
rash (1%) and diarrhea (2%), all of which were Grade 1 (mild) or
Grade 2 (moderate).
USE IN SPECIFIC
POPULATIONSPregnancyA pregnancy exposure
registry monitors pregnancy outcomes in women exposed to sotrovimab
during pregnancy. To enroll, go to https://covid-pr.pregistry.com/
or call 1-800-616-3791 to obtain information about the
registry.
There are insufficient data to evaluate a
drug-associated risk of major birth defects, miscarriage or adverse
maternal or fetal outcome. Sotrovimab should be used during
pregnancy only if the potential benefit justifies the potential
risk for the mother and the fetus. There are maternal and fetal
risks associated with untreated COVID-19 in pregnancy.
LactationThere are no available
data on the presence of sotrovimab in human milk, the effects on
the breastfed infant or the effects on milk production. Individuals
with COVID-19 who are breastfeeding should follow practices
according to clinical guidelines to avoid exposing the infant to
COVID-19.
About the GSK and Vir
CollaborationIn 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-19GSK’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-19Vir
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 pre-clinical 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 GSKGSK is a science-led
global healthcare company. For further information please visit
www.gsk.com/aboutus.
About Vir BiotechnologyVir
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. We routinely post
information that may be important to investors on our website at
www.vir.bio.
GSK Cautionary Statement Regarding Forward-Looking
StatementsGSK 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 2021 and any impacts of
the COVID-19 pandemic.
Vir Forward-Looking
StatementsThis 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, Vir’s collaboration
with GlaxoSmithKline, planned discussions with global regulatory
agencies, the timing of availability of pre-clinical data, data
disclosures and publications related to sotrovimab. Many factors
may cause differences between current expectations and actual
results, including unexpected safety or efficacy data observed
during pre-clinical or clinical studies, challenges in the
treatment of hospitalized patients, difficulties in collaborating
with other companies or government agencies, 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 US 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.
Registered in England & Wales:No.
3888792
Registered Office:980 Great West RoadBrentford,
MiddlesexTW8 9GS
Vir Biotechnology Contacts:
Investors
Heather Rowe Armstrong
VP, Investor Relations
harmstrong@vir.bio
+1 415 915 4228
Media
Cara Miller
VP, Corporate Communications
cmiller@vir.bio
+1 415 941 6746
GSK inquiries:
Media inquiries:
Tim Foley +44 (0) 20 8047 5502 (London)
Madeleine Breckon +44 (0) 20 8047 5502 (London)
Kathleen Quinn +1 202 603 5003(Washington DC)
Lyndsay Meyer +1 202 302 4595 (Washington DC)
Analyst/Investor inquiries:
Nick Stone +44 (0) 7717 618834 (London)
Sonya Ghobrial +44 (0) 7392 784784 (Consumer)
James Dodwell +44 (0) 20 8047 2406 (London)
Mick Readey +44 (0) 7990 339653 (London)
Josh Williams +44 (0) 7385 415719 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)
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