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December 3, 2021

Coronavirus company news summary – UK approves new Covid-19 treatment Xevudy – EMA begins rolling review of Valneva’s vaccine after positive early data

By Darcy Jimenez

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of Xevudy (sotrovimab) for Covid-19 treatment after it was found to reduce hospitalisation and death by 79% in high-risk adults. Developed by GSK and Vir Biotechnology, the monoclonal antibody was approved for use in individuals with mild to moderate Covid-19 with at least one risk factor for developing a severe infection. MHRA recommended the use of sotrovimab within five days of symptom onset.

The human medicines committee of the European Medicines Agency (EMA) has initiated a rolling review of Valneva’s Covid-19 vaccine VLA2001. The review was initiated following positive preliminary results received from laboratory studies and early clinical studies in adults. VLA2001 includes inactivated SARS-CoV-2 virus and two adjuvants to trigger an immune response. EMA’s rolling review accelerates assessment of a promising medication.

ARCA biopharma has completed enrolment for a study that seeks to assess rNAPc2 as a potential treatment for hospitalised Covid-19 patients. A total of 160 patients were enrolled in the Phase IIb ASPEN-COVID-19 trial at multiple clinical investigative sites in the US, Argentina and Brazil. In the study, two dose regimens of rNAPc2 will be evaluated versus heparin in hospitalised Covid-19 patients with an elevated D-dimer level. The company is expected to report top-line data of the study in the first quarter of 2022.

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