The US Federal Drug Administration (FDA) have provided emergency approval for the use of AstraZeneca’s Evusheld (formerly AZD7442) antibody combination for pre-exposure prophylaxis (prevention) of COVID-19.
Dr Kovilen Sawmynaden, Principal Scientist at LifeArc, said:
“LifeArc is a medical research charity. We were part of the BIA Antibody Taskforce to identify potential neutralising antibodies for SARS-CoV-2, donating our time and efforts on this project.
“This FDA approval for the AZ antibody therapy in the US for pre-exposure prophylaxis of Covid-19 is great news for a significant group of immunocompromised people who don’t respond and/or cannot have the vaccine. This includes patients currently receiving cancer treatments, who have had solid-organ transplants or are immunodeficient for other reasons.
“This type of medicine is a ‘prophylactic,’ which means it can be used to prevent COVID-19. However, there is an important distinction to be made between those individuals, which have been exposed to the virus (post-exposure prophylaxis) and those which have not (pre-exposure prophylaxis). In the case of this new drug, it has demonstrable efficacy in the latter and not the former.
“As it can be administered intramuscularly, this should help delivery of the drug outside a dedicated hospitalised setting. It has been cleverly designed to have a long ‘half-life’, which in practical terms means it is only likely to require administration a maximum of 1-2 times per year. However, efficacy against Omicron is still to be determined and it will be interesting to see how future-proof this drug remains.
“Recently approved monoclonal drugs in the UK are currently only available as treatment options. Because of this, this new drug would bring real value in our fight to help protect the UK’s immunocompromised population, if a similar application was to be made to the MHRA.”
Prof Penny Ward, Independent Pharmaceutical Physician, Visiting Professor in Pharmaceutical Medicine at King’s College London, said:
“Immunosuppressed Americans can feel very happy at the announcement today that the FDA have issued Emergency Use Approval of Evusheld for the prevention of COVID. This long acting monoclonal antibody combination, which is given intramuscularly, facilitating its use in a community setting, was shown in the PROVENT trial to reduce the rate of symptomatic infection from 1 to 0.2%, a relative risk reduction of almost 80% (RRR 77% 95%CI 46,90). Given that most immunosuppressed individuals may not respond well to vaccination and so remain at risk of developing COVID if exposed despite vaccination this additional level of protection would considerably reduce their risk and enable them to return to a more normal life. Although the company has not yet completed testing against the omicron variant, pharmacology data on activity against other variants containing some of the same mutations suggests that activity might be preserved against this strain. A critical feature of this product is its long lasting effect, one shot being effective for at least 6 months based on currently available data and potentially for a longer period as the trial is ongoing. Evusheld is also under review by the MHRA currently. Given the benefit that such a product can provide for a patient segment at particular risk from COVID, an early decision is much to be desired, particularly if retained antiviral activity against the omnicron strain is confirmed.”
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Prof Penny Ward: “I am semi-retired, but I am owner/Director of PWG Consulting (Biopharma) Ltd a consulting firm advising companies on drug and device development. Between December 2016 and July 2019 I served as Chief Medical Officer of Virion Biotherapeutics Ltd, a company developing antiviral treatments for respiratory viral diseases. Previous employee of Roche, makers of tocilizumab (anti IL6 antibody) and CMO of Novimmune, makers of empalumab (anti IFN gamma antibody).”
None others received.