Icosavax, Inc. has been granted Fast Track designation by the FDA for IVX-A12, a vaccine candidate that targets respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) in individuals aged 60 and above. This designation enables the drug to undergo an expedited review process, receive more frequent interactions with the FDA, and potentially qualify for accelerated approval and priority review.
Niranjan Kanesa-thasan, the Chief Medical Officer of Icosavax, stated that this regulatory milestone demonstrates the urgent need for a bivalent vaccine against RSV and hMPV. These viruses are the leading causes of pneumonia in older adults and are responsible for a significant number of hospitalizations and deaths in the United States. Icosavax is currently conducting a Phase 1 study of IVX-A12 with and without an adjuvant in up to 120 healthy older adults aged 60 to 75 years, with interim results expected in mid-2023. Following this, the company plans to initiate a Phase 2 trial in the second half of 2023.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!