08:14 AM EDT, 04/16/2024 (MT Newswires) -- GSK (GSK) said in a regulatory filing Tuesday that the US Food and Drug Administration has accepted for review the company's biologics license application for its meningococcal ABCWY vaccine candidate.

The pharmaceutical giant said the vaccine candidate provides broad coverage against the five most common groups of bacteria causing invasive meningococcal disease, and if approved, could reduce the number of injections involved in immunization.

The BLA submission is based on the outcomes of a late-stage trial in which all primary endpoints were met. The FDA has set Feb. 14, 2025, as the action date under the Prescription Drug User Fee Act for a regulatory decision on the application.