dm+d

Unassigned

New Medicines

EvusheldProphylaxis and treatment of mild to moderate coronavirus disease 2019 (COVID-19)

Information

Evusheld
New molecular entity
AstraZeneca
AstraZeneca

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Pre-registration (Filed)
Oct 21EMA start rolling review for prevention of COVID-19 in adults [8].
Oct 21AstraZeneca submit data to US FDA for Emergency Use Authorization (EUA) for AZD7442 for prevention of symptomatic COVID-19.[6]
Jun 21Following results of PIII STORM CHASER trial, the company are now awaiting results from the PIII PROVENT pre-exposure prevention trial and the PIII TACKLE study assessing the antibody in preventing more severe disease to understand the role of AZD7442 against COVID-19.[4]
Nov 20Filings planned for H1 2021 [3].
Oct 20Two Phase III clinical trials in more than 6,000 participants start at sites in and outside the US [1].

Category

Two long acting antibodies derived from convalescent plasma modified with extended half lives
COVID-19 is an infectious disease caused by coronavirus SARS-CoV-2. Most people infected experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems are more likely to develop serious illness [2].
Prophylaxis and treatment of mild to moderate coronavirus disease 2019 (COVID-19)
Intravenous infusion

Trial or other data

Nov 21In a new analysis covering cases up to Aug 29, AZS7442 reduced risk of symptomatic COVID-19 by 83% [9].
Aug 21In the PROVENT trial which enrolled 5,197 people who were expected to respond poorly or be intolerant to COVID-19 vaccines, or who were at increased risk of SARS-CoV-2 infection, two-thirds of subjects received AZD7442. Risk of symptomatic coronavirus infection was reduced by 77%. There were no cases of severe COVID-19 or deaths related to the virus in the AZD7442 arm. Three people on placebo developed severe COVID-19. Two of those participants died [5].
Jun 21Data read out from PIII STORM CHASER trial assessing AZD7442 failed to meet the primary endpoint of post-exposure prevention of symptomatic COVID-19 vs. placebo in unvaccinated adults exposed to an individual infected with COVID-19 within an 8 day period. AZD7442 reduced the risk of symptomatic COVID-19 by 33% vs. placebo and results were not statistically significant. However, in a subset of those who were positive for COVID-19 AZD7442 reduced the risk of developing symptomatic COVID-19 by 73% vs. placebo (in pts who negative at time of dosing) showing that AZD7442 reduced the risk of developing symptomatic COVID-19 by 92% >7 days after dosing, and by 51% up to 7 days following dosing [4].
Jan 21PIII TACKLE study to assess whether AZD7442 (a combination of 2 mAbs) can safely treat outpatient adults with COVID-19 and prevent either severe COVID-19 or death starts (NCT04723394). 900 adults will be randomised in a 1:1 ratio. Arm 1 (n=up to approximately 850) will receive a single dose (× 2 IM injections) of 600 mg of AZD7442; Arm 2 will receive placebo. Primary outcomes are a composite of either severe COVID-19 or death from any cause through Day 29, and safety measures; collection of these data is due to complete Aug 21 [5].
Dec 20PIII STORM CHASER study to assess the efficacy of AZD7442 for the post-exposure prophylaxis of COVID-19 starts (NCT04625972). 1,121 adults will be randomised in a 2:1 ratio to receive a single dose (× 2 IM injections) of either 300 mg of AZD7442 (n = approximately 750) or saline placebo (n = approximately 375) on Day 1. Collection of primary outcome data (incidence of the first case of SARS CoV-2 RT PCR positive symptomatic illness and safety measures) is expected to complete Apr 21 [5].
Nov 20PIII PROVENT trial to assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19 starts (NCT04625725). Approximately 5150 adults will be randomised in a 2:1 ratio; Arm 1 (n=approximately 3,433) will receive a single dose (× 2 IM injections) of 300 mg of AZD7442 and rm 2 (n=approximately 1717) will receive saline placebo. Patients will be recruited in the US and Europe, including UK. Collection of primary outcome data (incidence of the first case of SARS CoV-2 RT PCR positive symptomatic illness and safety measures) is expected to complete May 21 [5].
Oct 20PIII trials due to start - one will evaluate the safety and efficacy of AZD7442 to prevent infection for up to 12 months (n= 5,000). The second will evaluate post-exposure prophylaxis and pre-emptive treatment (n= 1,100 ) [1].