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 (5mg) & −1.7 (15mg) vs +0.9 for PBO, reflecting 22–23% improvement vs 12% worsening; MDS-UPDRS Part II+III combined scores were also improved (−9.7 & −10.2 vs +1.8)
- In TEMPO-2, Juvmo improved MDS-UPDRS Part II scores (−1.5 vs 0) & combined Part II+III scores (−10.3 vs −1.2). In TEMPO-3, Juvmo + levodopa increased daily “on” time without troublesome dyskinesia (1.7 vs 0.6hrs.) & reduced “off” time (1.9 vs 0.9hrs.). Efficacy was sustained through 85wks. (TEMPO-4); 93% pts on Juvmo + levodopa did not increase their levodopa dose, while 94% on Juvmo without levodopa did not initiate levodopa
Ref: PRnewswire | Image: AbbVie | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
