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News & Trends - Pharmaceuticals

AstraZeneca’s monoclonal antibody TGA approved for most at-risk, supplementing Pfizer and MSD COVID therapies

Health Industry Hub | February 28, 2022 |

Pharma News: AstraZeneca’s dual monoclonal antibody has been granted provisional approval in Australia by the Therapeutic Goods Administration (TGA) for the pre-exposure prophylaxis (prevention) of COVID-19 in adolescents and adults aged 12 years and older.

More than 40% of those hospitalised with COVID-19, despite being fully vaccinated, are people who are immunocompromised. Dr Paul Griffin, Director of Infectious Diseases at the Mater Health Services and Associate Professor at The University of Queensland, said vulnerable populations may need an additional layer of protection.

“We are extremely fortunate to have a number of safe and highly effective vaccine options that work tremendously well at protecting the majority of people. However, there are individuals who are unable to respond adequately to vaccination alone and therefore are at greater risk of infection. Evusheld represents another step forward in our ability to combat this virus by providing these people an option to add another layer of protection for those most at risk.”

Evusheld (tixagevimab and cilgavimab), a combination of two long-acting monoclonal antibodies is administered as two intramuscular injections and offers protection for those who are at high risk in the community, such as immunocompromised patients, or those unable to receive vaccination due to allergies or other intolerance of the vaccines. According to the company, Evusheld is not intended to be used as a substitute for vaccination against COVID-19.

Liz Chatwin, Country President, AstraZeneca Australia & New Zealand, said “We are so proud to continue to play a leading role in the fight against the COVID-19 pandemic, both at home in Australia and around the world. The approval of Evusheld brings welcome news for those immunocompromised and vulnerable population groups who may have not received adequate protection against COVID-19 to date.”

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Evusheld will supplement the existing National Medical Stockpile supplies of GSK’s Xevudy (sotrovimab), Gilead’s Veklury (remdesivir), MSD’s Lagevrio (molnupiravir) and Pfizer’s Paxlovid (nirmatrelvir + ritonavir).

Pfizer Australia told Health Industry Hub that the company’s agreement with the Government is to supply 500,000 treatment courses over 2022. Pfizer has already delivered its first shipment of Paxlovid with additional quantities to arrive in Q1 and throughout 2022.

MSD Australia also confirmed that 200,000 patient courses of Lagevrio have been delivered to the National Medicines Stockpile. MSD understands that the Government has prioritised access for Aboriginal Community Controlled Health Organisations, the Royal Flying Doctor Service and residential aged care facilities.

While agreements are in place around the world for the supply of Evusheld in 2022, including North America, within the EU and in the Middle East, the Australian Government has purchased an initial 36,000 doses of Evusheld which will soon become available for eligible at-risk patient populations within the community.


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