AbbVie Inc (NYSE:ABBV) received approval from the U.S. Food and Drug Administration for Juvmo, or tavapadon, tablets for the treatment of Parkinson’s disease.
According to the company, Juvmo is the first and only selective D1/D5 receptor agonist approved for the indication.
Approval Based on Phase 3 TEMPO Program
The FDA approval was supported by results from AbbVie’s Phase 3 TEMPO clinical development program.
The program showed improvements in daily functioning among patients treated with the drug, according to the source material.
The information provided did not include specific efficacy results, safety data or details regarding the approved patient population.
US Availability Planned for October
AbbVie plans to make Juvmo available in the United States in October.
The company did not provide pricing or additional commercial details in the source material.