Adverum gets FDA fast track for macular degeneration gene therapy

Adverum Biotechnologies 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). 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.
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