GSK Exec Praises Strong RSV Vaccine Start as Arexvy Expands for Adults 50-59

GSK's respiratory syncytial virus (RSV) vaccine, Arexvy, recently received approval from the FDA for an expanded age group. Initially approved in May 2022 for adults aged 60 and older, the vaccine is now also authorized for adults aged 50 to 59 who are at a higher risk of developing RSV disease. This move marks a significant step for GSK in its efforts to dominate the RSV vaccine market.

Len Friedland, M.D., Vice President and Director of Scientific Affairs and Public Health Vaccines at GSK, highlighted the potential benefits of this new approval. "There are approximately 13 million people in the U.S. between the ages of 50 and 59 who have underlying conditions that increase their risk of RSV," Friedland noted. Conditions such as congestive heart disease, asthma, chronic obstructive pulmonary disease, diabetes, and chronic kidney disease make these individuals particularly vulnerable.

Friedland emphasized that older age is a substantial risk factor for severe RSV outcomes, which often lead to hospitalizations and intensive care visits. "We estimate around 42,000 hospitalizations annually in adults aged 50 to 64 due to RSV," he said, pointing out the considerable opportunity to reduce these severe cases and potentially save lives.

The next significant milestone for Arexvy is its review by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, set for June 26. The committee's endorsement could lead to widespread adoption of the vaccine in the newly approved age range. "It’s crucial to transition the success we’ve seen in pediatric vaccinations to the adult population," Friedland explained.

Arexvy became the first globally approved RSV vaccine in May of the previous year, demonstrating an 82.6% efficacy in preventing RSV-related lower respiratory tract disease (LRTD) in older adults. Subsequently, Pfizer’s Abrysvo received approval for the same age group in June 2023, sparking intense competition. More recently, Moderna introduced its mRNA-based RSV vaccine, mRESVIA, also targeting adults aged 60 and older.

Friedland described the initial rollout of Arexvy as "extremely successful" due to the high unmet medical need when the vaccine was launched. In its debut RSV season, over 8 million people aged 60 and older in the U.S. received the vaccine. Arexvy currently holds more than 60% of the market, even as it faces competition from Pfizer’s Abrysvo. During the same period, 22% of U.S. adults aged 60 and above received an RSV vaccine, which Friedland considered "a great start."

Looking forward, GSK plans to further expand the reach of Arexvy. The company is conducting studies on the vaccine's effectiveness in adults aged 18 and older who are at increased risk of RSV due to immunocompromised conditions, such as solid organ transplants, as well as other underlying health issues. Results from these studies are expected in the latter half of 2024, after which GSK will approach the FDA again for further approvals.

Regarding the recent approval of Moderna’s mRESVIA, Friedland expressed a positive outlook. "Innovation and options are crucial. It’s our job to continue generating evidence that underscores the value of Arexvy," he said. "We believe we have the market-leading vaccine, and our objective is to maintain that position."

In the first quarter of 2023, Arexvy generated £182 million ($227 million) in sales, outperforming Pfizer’s Abrysvo, which garnered $145 million. Since its launch, Arexvy has accumulated £1.2 billion ($1.5 billion) in revenue, compared to Abrysvo's $1.03 billion.

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