Pharmaceuticals behemoth GlaxoSmithKline hopes to launch its maiden coronavirus treatment and, if all goes well, it will be destined for Australia.
The multibillion-dollar industry giant has received a “provisional determination” from the Therapeutic Goods Administration (TGA) for an antibody treatment called Sotrovimab.
“This allows the sponsor to apply for registration under this pathway. This is not an approval,” a TGA spokesperson told NCA NewsWire.
“If the TGA finds that this therapeutic is safe and effective, the TGA will grant a provisional approval.”
If it is provisionally approved, it would supplement the nation’s stalling vaccine rollout.
The company hopes the drug will be effective in treating patients with mild to moderate coronavirus infections.
Sotrovimab is a monoclonal antibody and not a vaccine, the TGA spokesperson explained.
Antibodies are proteins produced by the immune system and are one of the main ways the body defends itself against diseases. They work by binding to a specific target, like a virus or bacteria.
They then block or slow down the virus or bacteria, or they flag it as a ‘foreign body’ so that other parts of the immune system can fight it off.
Monoclonal antibodies are laboratory-made proteins that mimic the body’s immune system and would work in a similar way.
“Monoclonal antibodies can also help to ‘turn down’ an immune response when the body is over reacting, which is what can happen with some COVID-19 patients,” the TGA spokesperson said.
“That is, monoclonal antibodies may help to treat people who already have COVID-19.”
But the TGA urged people not to get ahead of themselves.
A statement from the company said provisional determination was the first step in the lengthy process and did not mean that an application had or would be made, or that the treatment would be provisionally approved.
“The provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data,” the statement read.
“In making its decision to grant GSK a provisional determination, the TGA considered all eligibility criteria, including factors such as the evidence of a plan to submit comprehensive clinical data and the seriousness of the current COVID-19 pandemic.”
The federal government is currently racing to vaccinate Australians but experts have long warned more options need to be made available, particularly after the risks associated with the AstraZeneca jab came to light.
In October last year, GSK announced plans to shut down its Melbourne manufacturing site in Boronia at the end of 2022 after five decades of operations.
“We are ensuring GSK is set up to deliver the next generation of innovative medications for patients,” GSK Australia pharmaceuticals general manager Christi Kelsey said at the time.
“In Australia, we are expecting to bring much-needed, innovative new medicines and vaccines every year as part of our forward plan.”