Image Credit: Indian Pharma Post
AbbVie, a leading biotech company, has proceeded with its submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for tavapadon, a selective dopamine D1/D5 receptor partial agonist, which was previously studied as a once daily oral treatment for parkinson’s disease.
The submission confidence is based on the last results from the TEMPO clinical development program that examined the tolerability, efficacy, and safety of tavapadon throughout a vast Parkinson’s disease population. This involves two phase 3 trials (TEMPO-1 and TEMPO-2) in early parkinson’s disease and a phase 3 trial (TEMPO-3) with patients facing motor fluctuation with tavapadon as adjunctive to levodopa.
The TEMPO-1 and TEMPO-2 studies showed that patients showed a proficient enhancement from baseline in the Movement Disorder Society's integrated parkinson’s disease rating scale (MDS-UPDRS) parts 2 and 3 merged score at week 26. The TEMPO-3 elaborated that patients showed more ‘on’ time, considering the period when symptoms were balanced without involuntary or dyskinesia movements. The submission is related to the interim data cut from TEMPO-4, an open-label extension (OLE) trial to evaluate the longstanding clinical benefit of tavapadon.
The MD, executive vice president, research and development, chief scientific officer at AbbVie, Roopal Thakkar, said, “For most of the individuals living with parkinson’s disease, the current oral standard of care is not effective enough to deal with the symptoms. We address the mental and physical impact that parkinson’s disease may cause and are dedicated to delivering next-generation treatment options that will help people recover motor control and freedom at all stages of this extreme disease.”
The submission is empowered by the results from the three placebo-controlled studies. The TEMPO-1 and 2 registered patients with early parkinson’s disease and TEMPO-3 who are on fixed-dose levodopa and motor fluctuation. An open-label extended study (TEMPO-4) is in progress for the evaluation of the long-term efficacy and safety of tavapadon via 58 weeks of treatment. The TEMPO-4 includes enrollment of patients with completion of participation in TEMPO-1 via 3, and patients on balanced doses of levodopa who are not primary in TEMPO trials.
The TEMPO-1 is a part of a phase 3 double-blind, placebo-controlled, parallel group randomized 27-week trial to examine the tolerability, efficacy, and safety of the two finalized doses of tavapadon in early parkinson’s disease. Alongside, TEMPO-2 was evaluated for flexible doses and TEMPO-3 for adjunctive therapy to LD for advanced parkinson’s disease.
Rushikesh Mane, Master of Science, is a healthcare sector expert who delivers insightful and impactful news for Towards Healthcare, focusing on industry developments, policy updates, and scientific innovations.
