The FDA has approved AbbVie’s Juvmo (tavapadon) tablets for adults with Parkinson’s disease, making it the first and only selective D1/D5 receptor agonist approved for adults with the condition.
The once-daily treatment can be taken with or without oral levodopa therapy, according to a Sept. 28 news release. AbbVie expects to make Juvmo available to patients in the U.S. this month.
The approval was supported by the phase 3 TEMPO clinical trial program. In TEMPO-3, Juvmo 5-15 milligram plus oral levodopa increased total daily “on” time without troublesome dyskinesia by 1.7 hours at week 26, compared with 0.6 hours for placebo plus oral levodopa. Total daily “off” time decreased by 1.9 hours with Juvmo plus oral levodopa, compared with 0.9 hours with placebo plus oral levodopa.
Sustained efficacy was observed out to 85 weeks among participants who continued into the TEMPO-4 open-label extension period. Of those receiving Juvmo plus oral levodopa for 85 weeks, 93% did not increase their oral levodopa dose. Among those receiving Juvmo without levodopa, 94% did not initiate levodopa.
