Alternatives to key COVID-19 antibody drugs that have been used to protect immunocompromised Americans could become available within months, executives at pharmaceutical company AstraZeneca said Thursday. rice field. .
The company’s new experimental drug, now named AZD3152, is being tested in a trial called “Supernova” in hopes of preventing symptomatic infections in people with weakened immune systems. Results are expected to be announced by September, AstraZeneca.a spokeswoman confirmed to CBS News.
This could lead to a potential Emergency Use Authorization from the Food and Drug Administration to make the drug available by the end of the year, when another fall and winter resurgence of COVID-19 is expected.
The company has already tested it against current and previous strains of SARS-CoV-2 and has published encouraging early data from laboratory studies of the drug.
AstraZeneca’s Mene Pangaros told investors on this week’s earnings call, “In vitro studies show that AZD3152 neutralizes all COVID-19 variants, including the latest variant of concern, Arcturus. He said.
According to AstraZeneca, the drug could benefit about 2% of the population who are unable to mount an effective immune response from the COVID-19 vaccine.
“We hope to have AZD3152 available as a new preventative treatment in the second half of this year,” said Pangalos.
“Urgent case”
Federal officials have expressed concern about gaps in options for immunocompromised Americans, even as the pandemic emergency subsides.
The onslaught of immune-evading Omicron variants over the past year has partially limited Covid-19 treatment and prevention options for these more vulnerable patients.
AZD3152 relies on some of the same technology as its predecessor Evusheld, which was approved in hopes of protecting immunocompromised Americans from infection.
The FDA effectively withdrew its emergency use authorization for the prophylaxis in January.
According to AstraZeneca, its new AZD3152 drug, which is based on another antibody derived from B cells provided by people who have recovered from infections, has been designed to cover a “wider range of variants” than Evusheld for six months. It is done.”
Immunocompromised patients who eventually become infected can be treated with COVID-19 antiviral drugs such as Pfizer’s Paxlovid and Gilead’s Veklury treatment.However, these drugs only suppress the virus in immunocompromised patients. not excluded.
FDA’s Peter Marks said, “We have a monoclonal successor in the process of updating to get the next generation of variants, and we expect to hear more about them in the coming months.” said. last month, webinar Hosted by the National Infectious Diseases Foundation.
Other options that may benefit people with weakened immune systems, such as GSK’s monoclonal antibody treatment sotrovimab, are also being hampered by the new Omicron strain.
“Obviously, there’s an urgent issue because it would be nice to have something for immunocompromised individuals,” Marks said.
The Biden administration has blamed a lack of funding from Congress for hampering the production of new antibody drugs for COVID-19, but a new infusion of some federal money is now planned.
“I think it was very clear that we were short of COVID dollars. We have pointed this out over and over again, but we didn’t have the winter surge we expected, we had extra funding.” Dawn O’Connell said at a House hearing last week.
Federal officials recently announced they were able to free up $5 billion for their “Project NextGen” efforts to subsidize new vaccines and antibody drugs.
“We believe creating the next generation of tools to protect Americans from COVID is a reasonable use of these next dollars,” O’Connell said.
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