Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition
The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research
Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US to prevent Covid-19
Expanded EUA includes both treatment of patients with Covid-19 and post-exposure prophylaxis (PEP) in high-risk pediatric and infant patients
This further adds to Biocon’s portfolio of vertically integrated complex drug products
Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic Covid-19, with no severe disease or deaths
Data demonstrates Ronapreve reduced risk of hospitalisation in certain patients and reduced risk of symptomatic Covid-19 infections in people exposed to the virus
A final decision regarding the approval of Ronapreve is expected from the European Commission shortly
AZD7442 reduced risk of developing severe Covid-19 or death in Tackle Phase III outpatient treatment trial
The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)
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