The UK has apparently opted against purchasing dosages of AstraZeneca’s prophylactic Covid-19 therapy Evusheld at this time, weeks after the evidence revealed current Omicron subvariants may be less vulnerable.
The UK’s Department of Health said it won’t procure Evusheld doses due to “insufficient data on the duration of protection offered by Evusheld in relation to the omicron variant,” according to the BMJ, a peer-reviewed trade journal published by the British Medical Association.
Evusheld, which is a combination of tixagevimab and cilgavimab, will now be evaluated by the National Institute for Health and Care Excellence (NICE).
However, that report isn’t expected until next April, according to the BBC, which was among the first to report the news.
Meanwhile, AstraZeneca said it will “seek further discussions” with the UK.
“We will be seeking further discussions with the government,” an AstraZeneca spokesperson told Endpoints News in an email.
The drug was authorized in the US back in December, based on data that suggested recipients saw protection through six months.
In a primary analysis, recipients saw a 77% reduced risk of Covid infection compared to placebo, according to the FDA.
In June, feeling pressure from Omicron subvariants, the FDA updated the Evusheld fact sheet to recommend repeat dosing every six months with 300 mg.
“Nonclinical data and pharmacokinetic modelling suggest that activity against these subvariants [BA.2, BA.2.12.1, BA.4, and BA.5] may be retained for six months at drug concentrations achieved following an Evusheld dose of 300 mg of tixagevimab and 300 mg cilgavimab,” regulators noted at the time.
However, July correspondence in the New England Journal of Medicine suggested that current Omicron subvariants may be less susceptible to AstraZeneca’s blockbuster drug.
“However, in clinical use, these variants may be less susceptible to combination therapy with casirivimab and imdevimab and with tixagevimab and cilgavimab,” the researchers wrote.
And on the company’s Q2 call, execs maintained that “efficacy is remaining very robust.”
“The main limitation of our study is the lack of clinical data on the efficacy of these monoclonal antibodies and antiviral drugs for the treatment of patients infected with BA.2.12.1, BA.4, or BA.5 subvariants,” researchers noted in the NEJM piece.
Sales for Evusheld and the company’s Covid-19 vaccine Vaxzevria were down last quarter compared to Q1 2022, coming in at $445 million and $451 million, respectively.
While CEO Pascal Soriot expects Vaxzevria sales will continue to fall this year, he thinks Evusheld will grow.
“We do believe that demand will continue.”
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Source: End Point News