AbbVie submits new drug application to USFDA for Tavapadon for Parkinsons disease
North Chicago: AbbVie has announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist that was studied as a once daily oral treatment for Parkinson's disease.
The submission is based on results from the TEMPO clinical development program that evaluated the efficacy, safety and tolerability of tavapadon across a broad Parkinson's disease population. This includes two Phase 3 trials (TEMPO-1 and TEMPO-2) in early Parkinson's disease, and one Phase 3 trial (TEMPO-3) with tavapadon as adjunctive to levodopa in patients experiencing motor fluctuations. TEMPO-1 and TEMPO-2 demonstrated that patients experienced a statistically significant improvement from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26. TEMPO-3 demonstrated that patients experienced more "on" time, referring to the period when symptoms were well controlled without dyskinesia or involuntary movements. The submission is also based on an interim data cut from TEMPO-4, an open-label extension (OLE) trial to assess the long-term clinical benefit of tavapadon.
"For many people living with Parkinson's disease, today's oral standard of care isn't effective enough to manage symptoms," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "We recognize the physical and mental impact that Parkinson's disease can cause and are committed to providing next-generation treatment options that will help individuals regain motor control and independence at all stages of this challenging disease."
More than 11 million people worldwide are living with Parkinson's disease, a progressive and chronic neurological disorder characterized by tremor, muscle rigidity, slowness of movement and difficulty with balance. The motor symptoms of Parkinson's disease begin when approximately 60-80 percent of the dopamine-producing cells in the brain are lost, and symptoms continue to worsen slowly over the course of time. As Parkinson's disease progresses, patients experience complications, including motor and non-motor fluctuations and dyskinesia. Patients report switching from an "on" state (when symptoms are generally well controlled) to an "off" state, during which symptoms such as tremor and stiffness may reappear and patients have more difficulty moving. Patients with advanced Parkinson's disease may also experience dyskinesia (involuntary movements) which can significantly hinder daily activities. While there is no known cure for the disease, there are treatments available to help reduce symptoms.
