AbbVie Seeks FDA Nod for Tavapadon to Treat Parkinson's Disease

Core Insights - AbbVie has submitted a regulatory filing to the FDA for its investigational drug tavapadon as a once-daily oral treatment for Parkinson's disease [1][8] - The FDA filing is backed by results from three late-stage studies (TEMPO-1, TEMPO-2, TEMPO-3) showing symptomatic improvement in a broad Parkinson's disease population [2][8] - If approved, tavapadon would be AbbVie's second recent FDA clearance for Parkinson's disease, following the approval of Vyalev [3][8] AbbVie's Neuroscience Portfolio - AbbVie has developed a strong neuroscience segment, initially led by blockbuster drugs like Botox Therapeutic and Vraylar, and has expanded to include migraine treatments Qulipta and Ubrelvy, as well as Vyalev [7][10] - Sales from the neuroscience franchise now account for over 17% of AbbVie's total revenues, with a nearly 21% year-over-year increase in the first half of 2025, driven by higher sales of Botox and other products [8][9] Recent Acquisitions and Investments - AbbVie acquired Cerevel Therapeutics for approximately $8.7 billion, adding tavapadon to its pipeline [4] - The company has also entered into an agreement to acquire Gilgamesh Pharmaceuticals' lead pipeline drug for nearly $1.2 billion, which is in mid-stage development for major depressive disorder [10] - AbbVie previously completed a $1.4 billion acquisition of Aliada Therapeutics, adding an investigational antibody for Alzheimer's disease [10] Setbacks and Challenges - The acquisition of Cerevel also included emraclidine, which faced development discontinuation after failing two phase II studies in schizophrenia, leading to a $3.5 billion impairment charge [11]