EMA concludes review of Lilly’s COVID-19 antibody therapies
The human medicines committee decided that there was significant evidence to endorse the use of a combination of bamlanivimab and etesevimab in outpatients at high risk of severe COVID-19.
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The human medicines committee decided that there was significant evidence to endorse the use of a combination of bamlanivimab and etesevimab in outpatients at high risk of severe COVID-19.
The sub-studies evaluating VIR-7831 and BRII-196 with BRII-198 have stopped enrolment based on recommendations from the Data and Safety Monitoring Board.
If approved for use, teplizumab could be the first drug able to delay the onset or completely prevent type 1 diabetes in at-risk groups.
Find out what the WHO has to say about the use of hydroxychloroquine in COVID-19 prevention and the results of a severe COVID-19 pneumonia trial with tocilizumab.
In a Phase III trial, tezepelumab was shown to meaningfully reduce annualised asthma exacerbation rates in a range of patients with severe, uncontrolled asthma.
The EMA’s committee adopted positive opinions of six medications, including two orphan drugs, and concluded its review of the use of REGN-COV2 – an investigational antibody therapy for COVID-19.
The EMA has begun a rolling review of Celltrion’s regdanvimab (CT-P59) antibody for COVID-19 and assessing new data on Veklury (remdesivir).
The approval was based on a Phase III trial in which Libtayo reduced risk of death by 43 percent in non-small cell lung cancer patients with ≥50 percent PD-L1 expression in their tumours.
The Emergency Use Authorization (EUA) for bamlanivimab and etesevimab was based on a trial where the antibodies lowered risk of hospitalisation and death in COVID-19 patients.
The ACTIV-3 sub-study will evaluate the safety and efficacy of the AZD7442 synthetic antibody combination in at least 150 participants with mild-to-moderate COVID-19.
The EMA's CHMP has begun a rolling review of REGN-COV2, Regeneron's COVID-19 antibody candidate, after successful pre-clinical trials.
In vitro neutralisation assays show REGEN-COV and AZD7442 are effective against the new SARS-CoV-2 variants, while other antibody therapies, including Eli Lilly’s bamlanivimab, were not.
Data from a Phase III trial shows high-risk patients treated with bamlanivimab and etesevimab were 70 percent less likely to be hospitalised due to COVID-19.
Interim data from the Phase III trial evaluating REGEN-COV™ as a passive vaccine to prevent COVID-19 finds it reduces overall infection rate, viral load and length of infection.
The additional doses of casirivimab and imdevimab, two monoclonal antibodies, will be used in non-hospitalised COVID-19 patients.