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.