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AstraZeneca PLC on Tuesday said its Evusheld treatment for Covid-19 has been approved for use in the EU.
The approval was based on results from the Tackle Phase III Covid-19 treatment trial. This trial showed one intramuscular dose of Evusheld provided ‘significant’ protection against progression to severe Covid-19 or death compared to placebo.
Evusheld reduced the risk of developing severe Covid-19 or death from any cause by 88% compared to placebo and the risk reduction was 67% compared with placebo when participants received Evusheld within five days of symptom onset
Tackle was conducted in non-hospitalised adults with mild-to-moderate Covid-19 who were symptomatic for seven days or less. 90% of trial participants were at high risk of progression to severe Covid-19 due to co-morbidities or age. Evusheld was ‘generally well tolerated’, AstraZeneca noted.
Evusheld was granted marketing authorisation in the EU for prevention of Covid-19 and is already available in a majority of countries in Europe.
Regulatory submissions are progressing for both prevention and treatment indications around the world.
Executive Vice President of Vaccines & Immune Therapies Iskra Reic said: ‘Covid-19 remains an ongoing health concern for millions of Europeans and around the world, especially for those who may not be well-protected against the virus from vaccination. With this approval, Evusheld is now the only long-acting antibody combination available for both prevention and treatment of Covid-19 in Europe, allowing us to protect even more people from this devastating disease.’
Shares in AstraZeneca were trading 0.6% higher at 10,178.00 pence each in London on Tuesday morning.
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