Drug Approval | March 28, 2022
EU approves Evusheld to prevent Covid-19
Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months
Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months
Recommendation based on Phase III PROVENT trial showing a significant reduction in the risk of developing symptomatic COVID-19, with protection lasting at least six months
Recommendation is based on pivotal data from the phase III POLARIX study
The study was published recently in Genome Medicine, a leading international journal focused on translational, genomic-based medicine
The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe
If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.
The first wave of shipments includes several countries, such as Germany, France and Austria
Tepmetko is the first and only oral MET inhibitor to be approved in the European Economic Area for treating adult patients with advanced NSCLC harboring alterations leading to METex14 skipping, who require systemic therapy following prior treatment
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
First launches expected in H1 2022
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