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Respiratory Syncytial Virus: GSK’s Arexvy Receives Positive European Medicines Agency CHMP Opinion for Adults Aged 50-59 at Increased Risk

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Respiratory syncytial virus (RSV) is a significant cause of lower respiratory tract disease (LRTD) in adults, particularly those with underlying health conditions. GSK has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the approval of GSK’s RSV vaccine, Arexvy, to include adults aged 50-59 at increased risk for respiratory syncytial virus disease. This recommendation, a notable milestone, marks the first time CHMP has suggested this age group for an RSV vaccine, signaling a crucial step towards the extension of the marketing authorization by the European Commission, with a final decision expected by September 2024.

Arexvy, a recombinant adjuvanted RSV vaccine, has been approved in Europe since June 2023 for adults aged 60 and above for preventing RSV-LRTD. Expanding this approval to include adults aged 50-59 at increased risk would significantly impact public health. Adults with chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes are particularly vulnerable to severe consequences from respiratory syncytial virus infections. These conditions can be exacerbated by RSV, leading to pneumonia, hospitalization, or even death.

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Respiratory Syncytial Virus: Substantial Health Burden and Positive CHMP Opinion for GSK’s RSV Vaccine Based on Phase III Trial

RSV poses a substantial health burden, causing approximately 270,000 hospitalizations and 20,000 in-hospital deaths annually in adults 60 years and older in Europe. The disease burden in adults aged 50-59 at increased risk is similar to that of the older population. The positive CHMP opinion is supported by results from a Phase III trial (NCT05590403) that evaluated the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to underlying medical conditions.
 The vaccine, containing recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant, has shown promising results.
It was approved by the US Food and Drug Administration (FDA) for adults aged 50-59 at increased risk on June 7, 2024. GSK has also filed regulatory submissions in Japan and other regions, with decisions under review. Trials evaluating the vaccine’s immunogenicity and safety in adults aged 18-49 at increased risk due to underlying medical conditions and in immunocompromised adults aged 18 and over are expected to yield results in the second half of 2024.
GSK’s commitment to combating respiratory syncytial virus is evident in their comprehensive approach to vaccine development and approval. The expansion of Arexvy’s indication is based on robust clinical evidence and addresses a critical need in public health. By extending protection to a younger at-risk population, GSK aims to reduce the incidence of severe RSV-related complications and hospitalizations.

Respiratory Syncytial Virus

Respiratory Syncytial Virus: GSK’s Arexvy Utilizes Proprietary AS01 Adjuvant System to Elicit Strong Immune Response

The proprietary AS01 adjuvant system used in Arexvy includes the STIMULON QS-21 adjuvant licensed from Antigenics Inc., a subsidiary of Agenus Inc. The vaccine’s efficacy is supported by its ability to elicit a strong immune response, although it is noted that, as with any vaccine, a protective immune response may not be elicited in all individuals.

The CHMP’s recommendation underscores the vaccine’s potential to provide significant public health benefits by preventing RSV-related LRTD in a broader age range. This expansion is particularly important given the increased vulnerability of adults with underlying health conditions who face heightened risks from RSV infections.

In conclusion, the positive CHMP opinion on expanding the approval of GSK’s Arexvy to include adults aged 50-59 at increased risk represents a significant advancement in the fight against respiratory syncytial virus. This decision, pending final approval by the European Commission, highlights the importance of addressing the needs of at-risk populations and underscores the ongoing efforts to improve public health outcomes through vaccination. With regulatory reviews ongoing in multiple countries, Arexvy continues to pave the way for broader protection against RSV, reinforcing GSK’s commitment to innovation and patient care. As the final decision from the European Commission approaches, the potential impact of this expanded approval on public health and the well-being of at-risk adults in Europe is immense.

 

Resource: Glaxo Smith Kline, July 29, 2024


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