Thursday, September 20, 2018
Adverum Biotechnologies, Inc., a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ADVM-022. ADVM-022 is a novel gene therapy candidate for the treatment of wet age-related macular degeneration (wAMD).
“The FDA’s Fast Track designation is an important recognition of our ADVM-022 gene therapy program,” said Leone Patterson, interim president and chief executive officer of Adverum Biotechnologies. “We look forward to working with the FDA and benefiting from the potential expedited development and regulatory path offered by their Fast Track program.”
A Fast Track designation is intended to facilitate the development and expedite the review of drugs and biologics to treat serious conditions and fill unmet medical needs. The designation enables more frequent communication with the FDA throughout a product candidate’s development and review process. The designation also provides eligibility for Priority Review and Accelerated Approval, which may potentially result in a shorter FDA review process.
