dm+d

Unassigned

New Medicines

Coronavirus disease 2019 (COVID-19) - early treatment in patients who are at high risk of hospitalization

Information

New molecular entity
Vir Biotechnology and GSK
Vir Biotechnology and GSK

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Pre-registration (Filed)
Jul 21GSK and Vir Biotechnology announce joint procurement agreement with European Commission to supply up to 220,000 doses of sotrovimab for treatment of adults & adolescents (aged ≥12 years; ≥40 kg) with COVID-19 who do not require oxygen and who are at risk of progressing to severe COVID-19 [13].
Jun 21The EMA has identified five "most promising" COVID-19 therapeutics already in an advanced stage of development that it will prioritise, with the aim of providing more regulatory flexibility with rolling reviews, conditional marketing authorisations and flexible labelling and packaging requirements. At least three of these new products will be authorised by Oct 2021. Sotrovimab is one of the 5 products [11].
Jun 21Wholesale acquisition cost of sotrovimab in the US is $2,100. The company plan to file for full approval in the US in H2 2021 [12]
May 21EMA issue positive opinion for early access to sotrovimab. Vir Biotechnology and GlaxoSmithKline are seeking full approval for their COVID-19 antibody by the end of the year [10].
May 21US FDA grants emergency use authorization to sotrovimab for mild-to-moderate Covid-19. Approval for use in adults and children aged ≥12 years weighing ≥40kg is based on interim data from PIII COMET-ICE trial in high-risk outpatients, which was halted early due to the observed efficacy [9].
Apr 21EMA is assessing sotrovimab for early access for use in patients with COVID-19 who do not require oxygen supplementation and are at high risk of disease progression. GSK is also preparing to submit a full marketing authorisation application [8].
Mar 21Vir Biotechnology and GlaxoSmithKline requested FDA emergency use authorisation [7].
Oct 20PIII registration trials commence in Northe America, South America and Europe [1].

Category

Fully human anti-SARS-CoV-2 monoclonal antibody
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].
Coronavirus disease 2019 (COVID-19) - early treatment in patients who are at high risk of hospitalization
Intravenous

Trial or other data

Jun 21Updated in vitro and in vivo (animal) laboratory data reports activity of sotrovimab is retained against 14 COVID-19 variants, including the delta variant [12]
Jun 21PIII data found sotrovimab reduced hospitalisations and deaths by 79% in adults with mild to moderate COVID-19 who were at high risk of disease becoming severe[10].
Apr 21PIII COMET-ICE study stopped early following interim review showing an 85% reduction in death and hospitalisation 29 days after randomisation [8].
Mar 21FDA EAU is based on interim analysis of PIII results which showed reduced hospitalization or death by 85% compared to placebo [7]. 27/03/2021 13:03:37
Mar 21three new trials announced: COMET-PEAK: PII trial with two parts to compare the safety and viral kinetics of 500 mg given IM with 500mg IV in low-risk adults with mild to moderate COVID-19 ; COMET-TAIL: PIII trial expected to begin Q2 2021 in high-risk adults to assess whether IM VIR-7831 can reduce hospitalisation or death due to COVID-19; COMET-STAR: PIII trial to begin Q2 2021 in uninfected adults at high risk to determine whether IM VIR-7831 can prevent symptomatic infection [6].
Mar 21Vir announce they are stopping a PIII trial early for efficacy after seeing an 85% reduction in hospitalisation or death at an interim review. [4].
Mar 21The VIR-7831 arm of the ACTIV-3 program has been closed to enrollment whilst data mature
Dec 20first patient dosed in new sub-trial of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalised adults. It will VIR-7831 with placebo in patients hospitalised with mild to moderate COVID-19 with fewer than 13 days of symptoms (n=300)[3].
Oct 20PIII portion of the COMET-ICE study will assess the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally (670 patients in the treatment arm and approximately 670 patients in the placebo arm). The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization or death within 29 days of randomization. Results expected Jan 2021 [1].