AbbVie Submits New Drug Application to U.S. FDA for Tavapadon for the Treatment of Parkinson's Disease

Core Viewpoint - AbbVie has submitted a New Drug Application (NDA) to the FDA for tavapadon, a novel treatment for Parkinson's disease, based on positive results from the TEMPO clinical development program [1][2][6]. Clinical Development Program - The submission is supported by results from the TEMPO clinical development program, which includes two Phase 3 trials (TEMPO-1 and TEMPO-2) for early Parkinson's disease and one Phase 3 trial (TEMPO-3) for patients on levodopa experiencing motor fluctuations [2][3]. - TEMPO-1 and TEMPO-2 showed statistically significant improvement in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26 [2][4]. - TEMPO-3 demonstrated increased "on" time without dyskinesia for patients on levodopa [2][6]. Trial Details - TEMPO-1 enrolled 529 adults aged 40-80 with early Parkinson's disease, evaluating two fixed doses of tavapadon over 27 weeks [4]. - TEMPO-2 involved 304 adults with flexible doses of tavapadon, also over 27 weeks [5]. - TEMPO-3 included 507 adults on stable doses of levodopa, assessing tavapadon as adjunctive therapy [7]. Safety and Efficacy - The majority of adverse events reported in the trials were non-serious and mild to moderate in severity, with low incidence of serious adverse events (SAEs) [8]. - Common adverse reactions included nausea, headache, and dizziness for patients without levodopa, and nausea and dyskinesia for those on adjunctive therapy [8]. Market Potential - If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease treatment by providing a once-daily oral option [6]. - More than 11 million people globally are living with Parkinson's disease, indicating a significant market opportunity for effective treatments [9]. About Tavapadon - Tavapadon is an investigational selective D1/D5 receptor partial agonist studied for use both with and without levodopa [10]. - It is not yet approved by any health regulatory authority [10]. AbbVie's Commitment - AbbVie has over three decades of experience in neuroscience and is dedicated to advancing treatment options for neurological disorders [11]. - The company aims to address serious health issues and improve the lives of patients through innovative medicines [12].