European Medicines Agency’s CHMP Issues Favorable Opinion for GSK’s Arexvy Vaccine for Adults Aged 50-59 at Higher Risk of RSV
Monday, July 29, 2024
GSK plc (LSE/NYSE: GSK) has revealed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the approval of GSK’s RSV vaccine. This extension would now cover adults aged 50-59 years at increased risk for RSV, in addition to the previously approved age group of 60 and older.
This recommendation is a significant milestone, marking the first instance where CHMP has suggested an RSV vaccine for the 50-59 age range. The final approval from the European Commission is expected by September 2024. Since June 2023, GSK’s Arexvy (a recombinant adjuvanted RSV vaccine) has been available in Europe for adults 60 and older to prevent RSV-LRTD.
Individuals with pre-existing health conditions like chronic obstructive pulmonary disease (COPD), asthma, heart failure, or diabetes are particularly vulnerable to severe RSV outcomes. RSV can exacerbate these conditions, leading to serious complications such as pneumonia, hospitalization, or even death. Each year in Europe, RSV is responsible for about 270,000 hospitalizations and 20,000 deaths among adults aged 60 and older. The impact of RSV on those aged 50-59 with increased risk is similar to that seen in the older population.
The CHMP’s recommendation is supported by findings from a Phase III trial (NCT05590403), which evaluated the vaccine’s safety and effectiveness in the 50-59 age group, including those with underlying medical conditions.
GSK’s RSV vaccine was approved by the US FDA for use in adults aged 50-59 at increased risk on June 7, 2024. The company is also seeking regulatory approval to expand the vaccine’s use in Japan and other regions. Further trials assessing the vaccine’s safety and efficacy in adults aged 18-49 with risk factors and in immunocompromised individuals are expected to conclude in the latter half of 2024.
The vaccine, containing recombinant RSV glycoprotein F in its prefusion conformation (RSVPreF3) combined with GSK’s AS01E adjuvant, was initially approved for adults 60 and older in Europe. As with any vaccine, not all individuals may achieve a protective immune response.
Globally, the vaccine has been approved in over 45 countries, including the US, for preventing RSV-LRTD in adults aged 60 and older. The vaccine’s trade name is still pending regulatory approval in some markets.
RSV is a widely spread virus that affects the lungs and breathing passages. It poses a significant risk to adults with underlying health conditions, weakened immune systems, or advanced age, potentially leading to severe health outcomes like pneumonia, hospitalization, and death. Annually, RSV results in around 470,000 hospitalizations and 33,000 deaths among adults aged 60 and older in high-income countries.
Source: gsk.com
