Visterra announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate, VIS410, a novel monoclonal antibody in development for the treatment of hospitalized patients with influenza A. Visterra is a clinical-stage biotechnology company that uses its novel Hierotope platform to identify unique disease targets and to design and engineer precision antibody-based biological medicines against such targets that are not adequately addressed with conventional approaches.
“We are pleased that the FDA has granted Fast Track designation to VIS410,” said Brian J.G. Pereira, M.D., president and chief executive officer of Visterra. “Severe influenza A is a serious disease, particularly dangerous in individuals with compromised immune systems, leading to as many as 700,000 hospitalizations and 56,000 deaths annually in the U.S.1 We are developing VIS410 as a single-dose treatment, and plan to initiate a Phase 2b clinical trial in hospitalized patients with influenza A in early 2018.”
Fast Track is the FDA process designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need. When granting Fast Track designation, the FDA evaluates whether a drug will affect factors such as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress to a more serious condition. With Fast Track designation, early and frequent communications between the FDA and the sponsor is encouraged throughout the drug development and review process to help to ensure that questions are resolved quickly, often leading to earlier drug approval.