2023-04-27 06:49:19 ET
- A panel of the European Medicines Agency (EMA) recommended the approval of GSK's ( NYSE: GSK ) respiratory syncytial virus (RSV) vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.
- The British pharma giant said this first time an RSV vaccine candidate for adults has gained a positive opinion.
- Currently, there are no RSV vaccines or specific treatments for older adults, according to the company.
- The European Commission (EC), which generally follows the opinion of the EMA's Committee for Medicinal Products for Human Use (CHMP), is expected to make a decision on the vaccine by July 2023.
- The filing was backed by data from reported more data from a phase 3 trial, dubbed AReSVi-006 .
- The GSK AS01 proprietary adjuvant system contains Agenus' ( AGEN ) QS-21 Stimulon adjuvant.
- The vaccine is also under review in the U.S. and Japan with decisions expected in 2023.
- GSK is in a race with Pfizer ( NYSE: PFE ) in the RSV arena as the U.S. company also has an RSV candidate waiting FDA approval and a potential launch this year.
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GSK RSV vaccine for older adults inches towards EU approval after EMA nod