UK not buying AstraZeneca’s COVID-19 antibody drug over lack of data
The U.K. has no plans to buy doses of AstraZeneca’s COVID-19 antibody therapy Evusheld that is designed to protect vulnerable people, arguing that the data for the drug is insufficient.
“Following a robust review of the available data, our clinical experts advise there is currently insufficient data on the duration of protection offered by Evusheld in relation to the Omicron variant and the government will not be procuring any doses at this time,” a government spokesperson said.
The injection is a combination of two antibodies and is designed to provide long-lasting protection against COVID-19. It was billed as a potential therapy to protect immunocompromised people, since they are unable to generate a strong immune response through vaccination.
AstraZeneca says, however, that there is data showing that Evusheld is effective against the Omicron strains, including BA.1, BA.2, BA.4 and BA.5, while clinical trials carried out before Omicron was first detected late last year showed protection lasted at least six months.
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The company also says that evidence from the use of this treatment outside of clinical trials, known as real-world evidence, is accumulating, with the therapy now used to protect people against the virus in 32 countries. Assessing this real-world data is likely to also demonstrate that the therapy provides long-lasting protection for vulnerable people against the current strains, the company argues.
The U.K.’s drugs regulator approved Evusheld for use on March 17, in what was hoped to be a lifeline for vulnerable patients, such as those who’ve had a transplant, cancer patients and people receiving treatment for autoimmune conditions like arthritis.
While the EU has not purchased doses for the bloc, countries including Germany, France and Spain have bought the treatment directly from AstraZeneca.
Meanwhile patient groups in the U.K. have been waiting.
People hearing this news today who have blood cancer or other conditions will be “feeling absolutely devastated,” Helen Rowntree, director of research at Blood Cancer U.K., told the BBC.
Many people are still shielding, unable to see their families, and are “not able to understand why that process is taking so long,” she added.
The government has referred the assessment to the National Institute for Health and Care Excellence, which weighs the costs and benefits of a product for the National Health Service.
It is also keen to see any new data that emerges from the worldwide use of the product.
“We are determined to support the most vulnerable as we live with COVID and immunocompromised patients are a priority for other treatments, access to free tests and vaccination,” the government spokesperson said.
“We continue to explore the market for promising treatments that could prevent infection, to add to the antibody and antiviral treatments that are already offered on the NHS.”