Covid-19 antibody drugs have been underperforming recently as ineffectiveness against omicron led the FDA to revoke their emergency authorization.AstraZeneca releases some positive antibody news new clinical data Demonstrate the durability of the protection afforded by its FDA-authorized drug mixture.
Results released late Wednesday showed that the antibody would have an increased risk of symptomatic Covid-19 compared with a placebo in a six-month follow-up of patients treated with AstraZeneca’s drug Evusheld. Risk was reduced by 83%.That brand is better than that Preliminary analysis reported last summer, when the company reported that the drug reduced the risk of infection by 77%. The median follow-up for this primary analysis was 83 days.The latest data from AstraZeneca drug is post In the New England Journal of Medicine.
Evusheld is a combination of two antibodies, tixagevimab and cilgavimab. Both antibodies were derived from B cells from patients who had recovered from Covid-19 infection. Each antibody binds to a different site on the SARS-CoV-2 spike protein, an approach designed to reduce the chance of mutations making the virus resistant to the drug. Evusheld uses proprietary AstraZeneca technology to extend the half-life of antibodies, allowing them to last up to a year.
this FDA granted emergency authorization to Evusheld in December Suitable for children 12 years and older as well as adults. The decision covers those who have a medical condition that weakens the immune system or who are taking drugs that suppress the immune system. Also included are those with a history of adverse reactions to components of the Covid-19 vaccine. According to AstraZeneca, about 2% of the global population is considered at risk of under-responding to the Covid-19 vaccine and is a candidate for Evusheld treatment. This group includes those who are immunocompromised, such as cancer patients and organ transplant recipients.
AstraZeneca is evaluating Evusheld’s Phase 3 study, which enrolled nearly 5,200 adults in the US and Europe. During the six-month follow-up period, AstraZeneca said there were no serious illnesses or Covid-19-related deaths in the Evusheld group. In contrast, the placebo group had five cases of severe or critical illness, seven hospitalizations and two Covid-19-related deaths.
Evusheld continued to be well tolerated by patients, with AstraZeneca reporting no safety concerns at the primary analysis or at the six-month mark. The most common adverse event was injection site reactions, which occurred in 2.4% of trial participants in the Evusheld group. AstraZeneca said additional data on how Evusheld moved throughout the body showed that blood levels of the drug remained high at the six-month mark, supporting the drug’s case for long-term protection.
The growing popularity of omicron and its sub-variants has resulted in reduced efficacy of several antibody drugs. Eli Lilly, Regeneron Pharmaceuticals and partners Vir Biotechnology and GlaxoSmithKline’s antibody drugs have had their emergency authorizations withdrawn. AstraZeneca’s drug shows signs of being able to fight these new strains.Last month, the company reported clinical data showing Evusheld Retain neutralizing activity For omicron and BA.2 sub-variants.
AstraZeneca is also evaluating Evusheld as a treatment for mild to moderate Covid-19 in non-hospitalized patients.In preliminary results of Phase 3 report In October, the company said the drug showed a statistically significant reduction in severe Covid-19, or deaths, compared with a placebo. The company is preparing to present the full results of the study at the European Congress of Clinical Microbiology and Infectious Diseases in July. AstraZeneca said the data had also been submitted to a peer-reviewed medical journal for publication.
Photo by AstraZeneca
