Continue to Site

Drug Discovery and Development

GSK’s RSV vaccine candidate for older adults wins priority review from FDA 

By |

GSKOn the heels of winning an EU nod for its RSV vaccine marketing authorization application, GSK (LSE/NYSE:GSK) has announced that FDA has accepted a Biologics License Application for its RSV vaccine candidate for older adults.

The agency also granted priority review to the vaccine, which will clip four months off the vaccine candidate’s biologics license application (BLA) review time.

The PDUFA date for the vaccine candidate is May 3, 2023.

Several other companies are also developing RSV vaccines, including Pfizer (NYSE:PFE), Icosavax (Nasdaq:ICVX) and Moderna (Nasdaq:MRNA).

GSK said that its RSV vaccine, if approved, would be the first to protect adults 60 and over from RSV infections, which can lead to pneumonia, hospitalization and death.

While researchers have sought to develop RSV vaccines since the 1960s, no vaccine against the virus is currently available.

In granting the BLA, FDA reviewed data from a prespecified interim analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) Phase 3 study.

Experts have warned that there could be a ‘tripledemic’ threat this winter season thanks to the risk of COVID-19, flu and RSV infections. The potential availability of one or more RSV vaccines by fall 2023 could help protect infants, young children and older people from the latter virus, which can be life-threatening in some cases.

In GSK’s clinical study involving adults 60 and older, the vaccine offered strong protection across the RSV A and B strains.

The company has announced the regulatory authorities in Europe and Japan have accepted regulatory submissions for the RSV vaccine.

The latest clinical trial data could indicate the GSK’s RSV vaccine candidate is more effective than Pfizer’s, according to the Financial Times. Although comparing results from disparate clinical trials is problematic, there was a substantial difference in the margin of protection in the GSK and Pfizer studies. GSK’s vaccine candidate had 82.6% overall efficacy, while Pfizer’s vaccine had an overall efficacy of 66.7%.

Despite the positive news, GSK shares dipped about 1% to $33.12.

Filed Under: clinical trials, Drug Discovery, Infectious Disease
Tagged With: ,
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Tell Us What You Think!

Related Articles Read More >

Search Drug Discovery & Development