Shots:
FDA approval was based on the P-III (TEMPO) program, which evaluated Juvmo in early PD pts not taking oral levodopa (TEMPO-1 & 2) & as an adjunct to oral levodopa vs PBO + levodopa in PD pts with motor fluctuations (TEMPO-3)
At Wk. 26 in TEMPO-1, Juvmo showed MDS-UPDRS Part II scores of −1.6…
Shots:
The US FDA has received an NDA for tavapadon (QD, PO) for Parkinson’s disease (PD), supported by P-III (TEMPO-1 & 2) trials in early PD & P-III (TEMPO-3) evaluating adjunctive use with levodopa in pts with motor fluctuations, plus interim data from P-III (TEMPO-4) open label study
TEMPO-1 (n=529) & TEMPO-2 (n=304) evaluated fixed…

