NDA is under review at the FDA.
The European Commission has sanctioned Boehringer Ingelheim’s prolonged-release, once-daily version of its Parkinson’s disease (PD) drug called Mirapexin®/Sifrol® (pramipexole). It is indicated for the treatment of early and advanced idiopathic PD.
The approval was based on the submission of clinical trial results showing that the new formulation can offer an efficacy and safety profile comparable to the immediate-release tablet, which is taken three times daily.
An NDA for the once-daily, extended-release formulation of pramipexole is under review with the FDA.