Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.AbbVie has filed a New Drug Application with the US Food and Drug Administration (FDA) for tavapadon, a selective dopamine D1/D5 receptor partial agonist that has been investigated as a once-daily oral treatment for Parkinson's disease.
The NDA submission is based on findings from the TEMPO clinical development programme. Credit: National Institute of Allergy and Infectious Diseases on Unsplash.
Subscribe to our email newsletter
The submission draws on findings from the TEMPO clinical development programme, which assessed the tolerability, efficacy, and safety of tavapadon in various populations with Parkinson’s disease.
This programme included two Phase III trials (TEMPO-1 and TEMPO-II focused on early Parkinson’s disease and one Phase III study investigating tavapadon as an adjunctive treatment to levodopa in patients facing motor fluctuations.
TEMPO-I and TEMPO-II showed a statistically significant improvement from baseline in the combined score of Parts II and III of the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) at week 26.
In TEMPO-III, patients reported an increase in “on” time, which refers to periods when their symptoms were well-managed without the presence of dyskinesia or involuntary movements.
The submission includes interim data from TEMPO-IV, an open-label extension trial that examines the long-term clinical benefits of tavapadon. This ongoing study assesses both efficacy and safety over a treatment period of 58 weeks.
AbbVie research and development executive vice president and chief scientific officer Roopal Thakkar said: “For many people living with Parkinson’s disease, today’s oral standard of care isn’t effective enough to manage symptoms.
“We recognise 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.”
