New preventative drug for COVID-19 Evusheld authorized in UK

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has reported that Evusheld, developed by AstraZeneca, has gained approval to help protect against the effects of COVID-19.

Following an extensive investigation of adult clinical trial data, the new therapy Evusheld (tixagevimab/cilgavimab) has met UK regulatory standards for safety, quality and efficacy. The combination drug consists of two long-acting antibodies that bind to the Spike (S) protein on the surface of the SARS-CoV-2 virus that causes COVID-19, preventing the virus from attaching to and entering cells. human cells.

Evusheld has been approved for use before being exposed to the risk of COVID-19 infection, with the aim of preventing disease. Although vaccination is the most effective means for such prevention, this new therapy is suitable for adults who are unlikely to mount an immune response following vaccination against COVID-19 or for whom vaccination is not recommended. according to the UK Medicines and Healthcare Products Regulatory Agency ( MHRA).

In the clinical trial for adults, the drug, which consists of two injections of the drugs tixagevimab and cilgavimab, was shown to reduce the risk of developing COVID-19 by 77%, with viral protection lasting at least least six months.

The agency reported that there is currently not enough data to verify Evusheld’s effectiveness against the Omicron variant, but it will work with AstraZeneca to establish it.

Commenting on the benefits of this new drug, Dr June Raine, Chief Executive of the MHRA, said: “Although COVID-19 vaccines continue to be the frontline defense against COVID-19, we know that some people may not respond adequately to these vaccines. vaccines and for a small number of people, COVID-19 vaccines may not be recommended for other reasons, such as a previous allergic reaction to any of the vaccine ingredients. For these people, Evusheld could provide effective protection against COVID-19. »

These efficacy results have been endorsed by the UK government’s independent scientific advisory board, the Commission on Human Medicines (CHM). CHM Chairman Prof Sir Munir Pirmohamed explained that “the recommended dosage is 300mg of Evusheld but a higher dose of 600mg may be more appropriate for some variants of COVID-19”. However, confirmed that: “Pre-exposure prophylaxis with Evusheld does not replace vaccination in individuals for whom COVID-19 vaccination is recommended.”