26th Mar 2021 13:41
(Alliance News) - GlaxoSmithKline PLC on Friday said, together with Vir Biotechnology Inc, it has submitted an application to the US regulator requesting emergency use authorization of VIR-7831 for the treatment with mild-to-moderate Covid-19.
The FTSE 100-listed pharmaceutical company said the submission to the US Food & Drug Administration is based on an interim analysis of efficacy and safety data from the phase 3 Cimet-Ice trial, which evaluated VIR-7831 as monotherapy for the early treatment of Covid-19 in adults at high risk of hospitalisation.
Results of the interim analysis, based on data from 583 patients enrolled in the trial, demonstrated an 85% reduction in hospitalisation or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial.
As a result, the independent data monitoring committee recommended that the trial be stopped for enrolment due to evidence of profound efficacy.
GSK and Vir will continue discussions with the European Medicines Agency and other global regulators to make VIR-7831 available to patients with Covid-19 as soon as possible.
In a separate statement, Brentford, England-based GSK said the committee for medicinal products for human use of the European Medicines Agency has adopted a positive opinion recommending the use of intravenous and subcutaneous Benlysta in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.
The committee's opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. If approved, Benlysta would become the first and only biologic approved for both systemic lupus erythematosus and lupus nephritis in the EU.
"Active lupus nephritis occurs in more than 1 million patients with systemic lupus erythematosus worldwide. It causes inflammation in the kidneys and can lead to end-stage kidney disease which may require dialysis or a transplant," explained Christopher Corsico, senior vice president of Development at GSK.
The EU regulator's opinion is based on data from the Bliss-LN study conducted in active lupus nephritis, involving 448 adult patients. The study met its primary endpoint demonstrating that a statistically significant greater number of patients achieved primary efficacy renal response at two years when treated with belimumab plus standard therapy compared to placebo plus standard therapy.
GSK shares were trading 0.5% higher in London on Friday at 1,291.40 pence each.
By Evelina Grecenko; [email protected]
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