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GSK: FDA approves vaccine against respiratory virus

( - GSK has announced that the US FDA has approved Arexvy (respiratory syncytial virus (RSV) vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) due to RSV in adults aged 50-59 at increased risk.

In the US, the vaccine is currently approved for use in adults aged 60 and over and recommended by the CDC/ACIP using shared clinical decision-making.

A systematic review of US studies found that RSV causes 42,000 hospitalizations each year in adults aged 50-64.

The regulatory application was supported by positive results from a Phase III trial evaluating the immune response and safety of GSK's RSV vaccine in adults aged 50-59, including those at increased risk of RSV-LRTD due to certain underlying medical conditions.

Adults with underlying medical conditions such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk of serious consequences from RSV infection compared to those without these conditions. RSV can exacerbate these conditions, leading to pneumonia, hospitalization or death.

GSK said that the approval reflects the importance of extending the benefits of RSV vaccination to adults aged 50-59 who are at increased risk. For people with underlying medical conditions, RSV can have serious consequences, so we're proud to be the first to help protect them against RSV-LRTD.

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