FDA Fast Tracks Altimmune, Aldeyra Drugs for Alcohol Use, Retinitis Pigmentosa

Altimmune, Inc. has received FDA Fast Track designation for its investigational drug pemvidutide to treat Alcohol Use Disorder (AUD), a condition affecting over 28 million adults in the U.S. with only 2% receiving medication-based treatment. Pemvidutide, a dual GLP-1/glucagon receptor agonist, is being evaluated in a Phase 2 RECLAIM trial for its potential to reduce alcohol intake and address liver inflammation. Meanwhile, Aldeyra Therapeutics has also been granted FDA Fast Track designation for ADX-2191, a methotrexate intravitreal injection targeting retinitis pigmentosa, a rare genetic eye disease affecting over one million people worldwide with no approved therapies. Supported by positive Phase 2 trial results showing improved retinal sensitivity, Aldeyra plans to initiate a Phase 2/3 trial in 2025 to further assess the drug’s safety and efficacy. Both designations aim to expedite the development and review of these drugs to address significant unmet medical needs in their respective fields. Aldeyra’s CEO emphasized that the Fast Track and Orphan Drug designations create a framework for ADX-2191 to potentially reach patients promptly if approved.