AstraZeneca asks US FDA to authorise long-lasting preventative COVID-19 treatment

AstraZeneca has asked the US Food and Drug Administration to authorise the emergency use of a first-of-a-kind antibody treatment to prevent COVID-19.
An Australian specialist described the treatment as “important” but with “niche” uses.
Key points:
- The drug would be given as a preventive measure and last for up to a year
- Late-stage human trials showed it reduced the risk of developing symptomatic COVID-19 by 77 per cent
- The company is capable of producing dose quantities in the “low millions”
The Anglo-Swedish company said the treatment, known as AZD7442, would be the first long-acting antibody combination to receive an emergency authorisation for COVID-19 prevention.
If authorised, the drug would likely be limited to people with compromised immune systems who do not get enough protection from vaccination.
“First and foremost we want to protect those vulnerable populations that haven’t been adequately protected by the vaccine,” Menelas Pangalos, AstraZeneca’s head of research and development, said.
Dr Pangalos said the company’s long-acting formulation was designed to boost immunity for up to one year, compared with existing drugs that offer a month or two of protection.
The FDA has authorised three other antibody drugs — laboratory-made versions of virus-blocking antibodies that help fight off infections — including two that can be given after possible COVID-19 exposure to head off symptoms.
AstraZeneca’s drug would instead be given as a preventive measure in people who have increased vulnerability to the virus.
Dr Pangalos said the company’s drug would provide “an additional option to help protect against COVID-19 alongside vaccines”.
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‘We welcome additional tools’
Westmead Hospital paediatric infectious diseases specialist Philip Britton told the ABC the drug would likely have a “niche” but “important” role in the fight against COVID-19.
Dr Britton said it was important to note that AZD7442 was a third class of pharmaceutical intervention, different from anti-viral drugs and vaccines.
“This is an example of immuno-prophylaxis, so we are giving people antibodies or immune proteins specific to the SARS-COV-2 virus that allow them to be immunologically protected from the virus for a period of time,” Dr Britton said.
He said immuno-prophylactics served a similar role to vaccines, preventing infection in people who are likely to be exposed.
However, because the protection provided is only temporary and likely not as “robust” as the immunity induced by vaccines, they are most useful for people in whom vaccination is not effective, such as those receiving cancer therapy or organ transplants.
“We welcome additional tools,” he said. “This will have use with specific groups in which the vaccines either can’t be used or haven’t been successful in promoting an immune response.”
No substitute for vaccination
The FDA has also stressed that antibody drugs are not a substitute for vaccination, which it says is the most effective, long-lasting form of virus protection.
Antibody drugs are also expensive to produce.
According to AstraZeneca, late-stage human trials showed the AZD7442 treatment reduced the risk of developing symptomatic COVID-19 by 77 per cent.
More than three-quarters of the participants had suppressed immune systems due to cancer, lupus and other conditions that made them more susceptible to severe disease.
The company will also seek regulatory authorisation in Europe and other regions across the world.
US demand for the treatments soared over the summer, particularly in states like Florida, Louisiana and Texas, where unvaccinated patients threatened to overwhelm hospitals.
The main antibody treatments being used in the US are from Regeneron and Eli Lilly & Co.
The US government has purchased bulk quantities of both drugs and oversees their distribution to the states.
AstraZeneca said it was in purchase talks with the US and other governments around the world.
If authorised, Dr Pangalos said the company was capable of producing dose quantities in the “low millions”.
ABC/AP