GSK News & Events

The New England Journal of Medicine reports: "Sounding Board announces a new FDA policy that the default requirement for FDA approvals will be one robust pivotal trial plus confirmatory evidence, rather than two trials." Publicly traded companies in the space include AstraZeneca (AZN), Bristol Myers (BMY), Eli Lilly (LLY), GSK (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).

GSK announced new effectiveness data for its adjuvanted recombinant respiratory syncytial virus vaccine at RSVVW'26, the 9th Conference of the Respiratory Syncytial Virus Foundation in Rome, Italy. GSK is presenting 19 abstracts at the congress and supporting a further 3, reflecting GSK's leadership in research and prevention of RSV. For GSK's RSV vaccine, the study showed an association with 75.6% vaccine effectiveness against RSV-related hospitalisation at a median follow-up of 5.6 months post-vaccination. Further exploratory endpoints showed an association with 63.1% VE against major adverse cardiovascular events, including heart attack and stroke, during RSV-related hospitalisation among adults aged greater than or equal to 60 years

GSK announced that the European Commission has approved Exdensur in two indications: as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids plus another asthma controller; as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. The approval is based on data from the SWIFT and ANCHOR phase III trials, which showed sustained efficacy with a twice-yearly dosing regimen for depemokimab. Each of the four trials met their primary or co-primary endpoints with statistically significant and clinically meaningful results, comparing the addition of depemokimab to standard of care versus standard of care alone.

GSK announced that its regulatory application for Arexvy, has been accepted for review by China's Center for Drug Evaluation, CDE, for the prevention of lower respiratory tract disease, LRTD, caused by respiratory syncytial virus, RSV, in adults aged 60 years and older. If approved, Arexvy will be the first vaccine available to this population in China to help protect against the potentially serious consequences of RSV disease.