In June, the Advisory Committee on Immunization Practices (ACIP) will make recommendations on the appropriate use of the vaccine in the U.S.
FDA approved the first respiratory syncytial virus (RSV) vaccine for older adults anywhere in the world: GSK’s Arexvy (respiratory syncytial virus vaccine, adjuvanted). Arexvy prevents lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older.
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. The approval of the first RSV vaccine “is an important public health achievement to prevent a disease which can be life-threatening,” Marks added.
“Today marks a turning point in our effort to reduce the significant burden of RSV…Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries,” said Tony Wood, chief scientific officer of GSK.
GSK is committed to pricing its vaccine in a value-based way, a company spokesperson told Formulary Watch. “This will reflect the possible benefit it can offer in reducing the considerable public health issue of RSV in older adults.”
Arexvy’s final launch price “will reflect the full value we believe the vaccine can offer and it will support a competitive position within the market,” the spokesperson added.
GSK has begun “productive” talks with population-based decision makers, including payers with Medicare Part D plans, about timely coverage and reimbursement of Arexvy, according to the spokesperson. As a result of the Inflation Reduction Act, patients with Medicare Part D will have no out of pocket expenses for Arexvy.
"We will continue to engage customers with Medicare Part D plans to secure access for eligible older adults in the US as quickly as possible,” the spokesperson said.
The vaccine will be available for older adults ahead of the 2023/2024 RSV season in the U.S., which typically starts ahead of winter months.
In June, the Advisory Committee on Immunization Practices (ACIP) will make recommendations on the appropriate use of the vaccine in the U.S., the spokesperson said. “We are optimistic that these plans will begin to activate coverage following the ACIP recommendation in late June,” the GSK spokesperson added.
After granting priority review, the FDA is requiring GSK to conduct a postmarketing study to assess the signals of serious risks for Guillain-Barré syndrome and ADEM. In addition, although not an FDA requirement, the company has committed to assess atrial fibrillation in the postmarketing study, the FDA said.
RSV is a common, contagious virus that can lead to potentially serious respiratory illness. It causes approximately 177,000 hospitalizations and an estimated 14,000 deaths in the US in adults aged 65 years and older each year, GSK said. Older adults, including those with underlying medical conditions such as diabetes and chronic heart and lung disease, are at increased risk of severe RSV illness and drive the majority of RSV hospitalizations.
FDA’s approval is based on GSK’s landmark positive pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase 3 trial data. In the trial, the vaccine showed statistically significant and clinically meaningful overall efficacy of 82.6% against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint.
In addition, efficacy was 94.6% in older adults with at least one underlying medical condition of interest, such as certain cardiorespiratory and endocrine-metabolic conditions. Efficacy against severe RSV-LRTD, defined as an RSV-associated LRTD episode preventing normal, everyday activities, was 94.1%.
The vaccine was generally well tolerated with an acceptable safety profile. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, headache, and arthralgia, according to GSK.