An antibody cocktail given to Donald Trump when he contracted COVID-19 and now widely used in the United States has been conditionally recommended in Australia.
The National COVID-19 Clinical Evidence Taskforce (CET) has made a series of recommendations about the use of casirivimab plus imdevimab, or REGEN-COV, made by US company Regeneron.
The CET, which compiles the latest information from peak health authorities managing treatment of the virus in Australia, has put forward REGEN-COV for patients hospitalised with moderate to critical COVID-19 who have no detectable virus antibodies.
Such patients have multiple health risk factors including comprised immune systems.
In these people, the taskforce advises, the risk of death is “probably reduced”.
REGEN-COV, given by injection, is made of two monoclonal antibodies mixed together – hence the term “cocktail”. They mimic natural antibodies and stop the virus doing as much damage.
It is not currently approved by national drug regulator the Therapeutic Goods Administration. However pharmaceutical company Roche Australia is trying to have the antibody cocktail made available.
“Roche is exploring opportunities to make the investigational antibody cocktail available in Australia and will work with the government on a potential supply agreement if approved for use in Australia,” a spokesperson told AAP.
AAP understands Roche is waiting for approval and that this could come within weeks.
The company’s efforts come as severe cases in NSW rise. On Saturday, NSW Health reported 53 people in intensive care, including 27 being ventilated. There have been 14 deaths in the state’s current outbreak.
The federal health department confirmed on July 29 there had not yet been an application to the TGA for the drug’s approval in Australia.
The department said it was aware of the recommendations made by the CET.
“We are actively monitoring COVID-19 therapeutic development that is occurring both in Australia and around the world and are meeting with pharmaceutical companies to discuss progress and the application process,” a spokesperson told AAP.
“We are also part of a network of international regulators that meet regularly to discuss the development of COVID-19 therapies.”
The research body advises against the use of REGEN-COV for COVID-19 infected people who have antibodies to the virus.
In mild or asymptomatic COVID-19 cases, it recommends the drug combo’s use in research settings only and notes there is no available evidence on the use of the antibody cocktail in children, adolescents, pregnant and breastfeeding women or frail and older people.
The US drug regulator approved the Regeneron therapy for emergency use in COVID-19 patients in late 2020 in an attempt to prevent hospitalisations and worsening disease in patients with mild to moderate symptoms.
The Food and Drug Administration authorised the therapy in adults and children 12 and above and who are at high risk of severe illness because of age or medical conditions.
It is unclear whether the Regeneron drug was what helped former US President Trump recover from the virus.
See the recommendations made by the National COVID-19 Clinical Evidence Taskforce at covid19evidence.net.au/news/communique-47/