GSK's RSV vaccine first to get EU regulator's nod
RSV causes an estimated 250,000 hospitalisations and 17,000 in-hospital deaths In Europe annually
(Reuters) - The European Medicines Agency (EMA) on Wednesday recommended authorization of GSK's Arexvy vaccine for respiratory syncytial virus (RSV) in adults aged 60 and older, putting Europe on track to approve the world's first such vaccine.
The recommendation puts GSK ahead of rival Pfizer Inc. in the race to tap into the RSV vaccine market, which is estimated to exceed $5 billion and could surpass $10 billion by 2030, according to analysts.
British and U.S. drug makers are expecting a U.S. Food And Drug Administration (FDA) decision by May to allow the use of their RSV vaccines in the United States, where 14,000 people die annually from the lower respiratory tract disease caused by the common virus.
In Europe, RSV causes an estimated 250,000 hospitalisations and 17,000 in-hospital deaths every year in people aged 65 and older, EMA said.
RSV produces flu-like symptoms but it can be fatal for young children and older adults. The disease surged in the U.S. and Europe this fall, alongside the flu and COVID-19.
Both Pfizer and GSK had gained the backing of a panel of FDA advisers in late February and early March, bringing them a step closer to final U.S. approval.
U.S. biotech Moderna, another RSV vaccine developer, has said it plans to submit its mRNA-1345 for approval globally in the first half of 2023.
The EU regulator's recommendation is based on late-stage study data showing GSK's vaccine was 82.6% effective in preventing lower respiratory tract disease study in older adults. The trial, of about 25,000 adults aged 60 and over, showed the vaccine was 94.1% effective against severe lower respiratory tract disease associated with an RSV infection.
GSK is relying in part on its potential blockbuster RSV vaccine to drive long-term growth, with the pending loss of patent protection of its HIV compounds and setbacks in its marketed oncology portfolio.
The EMA said Arexvy was reviewed under its accelerated assessment route for its committee to recommend authorisation of drugs. EMA recommendations are usually followed by the European Commission in final decisions on drug approvals.
