First monoclonal antibody treatment approved for COVID-19 in Australia
GSK Australia and Vir Biotechnology have today welcomed the Therapeutic Goods Administration (TGA) provisional approval of sotrovimab, a monoclonal antibody (under the product name Xevudy), for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death1.
The design of monoclonal antibodies is based on the natural antibodies humans already make. The role of monoclonal antibodies is to bind to the virus, stop it entering host cells and help fight off already infected cells1.
Dr Krystal Evans, Medical Lead for COVID Therapeutics at GSK Australia, says the provisional approval is an important milestone in the strategy to combat COVID-19 in Australia.
“Sotrovimab is the first monoclonal antibody treatment approved for COVID-19 in Australia. We think this new treatment option could play a role in our longer-term management of COVID-19 as part of Australia’s pandemic response toolkit,” said Dr Evans.
“If we can treat people at the time of diagnosis, then we may be able to prevent the disease from getting more serious and help keep people out of hospital.
“Vaccines are a critical element in our response to the pandemic and we also need to have a range of interventions available if people do become infected, to keep people out of hospital and reduce the severity of the disease. This means social distancing, hand washing, mask-wearing, vaccination and effective evidenced-based treatment options.”
Associate Professor Paul Griffin, practicing infectious diseases physician and clinical microbiologist, said he welcomed the approval of an early treatment for COVID-19 in Australia.
“Having evidence-based medicines to provide early treatment for those most vulnerable to the virus is an important pillar in managing the pandemic,” said A/Prof Griffin.
“New treatment options have the potential to keep people out of hospital, prevent their disease from progressing and reduce the burden on the health system. These outcomes are a key objective in our management of COVID-19 in the community and new treatments will help us get there.”
Dr Evans said GSK Australia was proud to help bring this innovation to patients.
“Today’s announcement is welcome news for patients and the Australian community. It follows extensive work right around the world in collaboration with our partners at Vir Biotechnology,” concluded Dr Evans.
The TGA had previously granted sotrovimab a provisional determination in April, which provides a mechanism for accelerating the provisional registration of promising new medicines. The provisional approval pathway allows companies to apply for time-limited registration for a promising treatment for a serious or life-threatening condition.
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About Sotrovimab (previously VIR-7831)
Sotrovimab (Xevudy) is an investigational SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is 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’s Xtend™ technology, also has 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.
PLEASE REVIEW PRODUCT INFORMATION BEFORE PRESCRIBING.
Minimum Product Information
XEVUDY ▼ (sotrovimab) Concentrated injection solution for infusion
Indications: XEVUDY has provisional approval for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death. The decision has been made on the basis of short term efficacy and safety data. Continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.
Contraindications: Hypersensitivity to the active substance or any of the excipients
Precautions: Hypersensitivity reactions. In a study in patients hospitalised with COVID-19, hypersensitivity reactions, including serious reactions such as anaphylaxis, have been reported following infusion of sotrovimab. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration and initiate appropriate supportive care.
In COMET-ICE, mild to moderate hypersensitivity reactions have been observed. If mild to moderate hypersensitivity reactions occur, consider slowing or stopping the infusion along with appropriate supportive care.Pregnancy: Category B2. Lactation: No data in human milk. Fertility: No data in humans. Paediatric use: Safety and efficacy in children under 12 years of age or weighing less than 40kg has not yet been established. For further details, please refer to the full PI.
Interactions: No formal interaction studies have been performed. The efficacy and safety of sotrovimab in subjects who have received a COVID-19 vaccine at any time prior to its administration has not been established. The receipt of a COVID-19 vaccine within 48 hours prior to, or 4 weeks following treatment with XEVUDY has not been studied.
Adverse reactions: Diarrhea, hypersensitivity reactions (Includes rash, dermatitis contact, skin reaction, hypersensitivity, multiple allergies, infusion-related reaction and bronchospasm). One case of anaphylaxis was reported following infusion of sotrovimab in a study in hospitalized patients; the patient received adrenaline (epinephrine) and the event resolved. This is not a complete list, see full PI.
Dosage and Administration: Adults and adolescents (12 years or older and weighing at least 40 kg): recommended dose is a single 500 mg dose administered as an intravenous infusion over 30 minutes. It is recommended that XEVUDY is administered within 5 days of onset of symptoms of COVID-19. XEVUDY must be diluted prior to administration and must not be administered as an intravenous push or bolus injection. XEVUDY should be administered in healthcare facilities in which patients can be monitored during and for one hour after administration of XEVUDY. As part of risk stratification of patients the pivotal consideration is the comorbidities, alongside age, particularly multiple comorbidities. XEVUDY should not be used in patients hospitalised due to COVID-19. For further details, please refer to the full PI.
XEVUDY Min PI v2 For further details, please refer to the full PI.
▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
Full Product Information is available by contacting GSK Medical Information on 1800 033 109. PBS INFORMATION: This product is not listed on the PBS. For information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109. GlaxoSmithKline Australia Pty Ltd. ABN 47 100 162 481. Melbourne, VIC. © 2021 GSK group of companies or its licensor. XEVUDY is a registered trade mark of the GSK group of companies. PI-8601 Date of approval: August 2021
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About Vir Biotechnology
Vir Biotechnology is a clinical-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.
1 Sotrovimab PI
PBS Information: Sotrovimab is not listed on the PBS