Icosavax granted FDA Fast Track designation for IVX-A12

Icosavax announced the U.S. 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. "We are delighted to have received the Fast Track designation for IVX-A12, which we believe highlights the unmet medical need that could be addressed by developing a bivalent vaccine combination of RSV and hMPV," said Niranjan Kanesa-thasan, Chief Medical Officer of Icosavax. "IVX-A12 is differentiated as the most advanced vaccine candidate against these two leading causes of pneumonia in older adults. RSV is estimated to cause approximately 177,000 hospitalizations and 14,000 deaths each year in this population in the U.S. alonei and data support similar morbidity and mortality for hMPV. We will utilize the benefits of this important regulatory milestone to work to optimize the IVX-A12 development plan. In addition, we look forward to the upcoming topline results of our Phase 1 study, and thereafter to the planned initiation of our Phase 2 trial."