Icosavax, a biopharmaceutical company leveraging its innovative virus-like particle (VLP) platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases and a vision of creating pan-respiratory vaccines for older adults, announced the US Food and Drug Administration (FDA) has granted Fast Track designation for IVX-A12, a bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) VLP vaccine candidate, in older adults 60 years of age and above.
According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fulfill an unmet medical need. An investigational drug that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.