After seven years of trial and error, the FDA has finally offered a green light for Newron’s Parkinson’s drug safinamide after following two radically different paths to get it on the market in Europe and the US. Previously, FDA refused to even accept their first application in 2014, faulting them for a series of mistakes in the NDA.
Today, Newron and its new partners, Zambon and US WorldMeds, have cause for celebration. Safinamide will now be sold as Xadago by US WorldMeds, which did a deal with Zambon for the commercial rights. In two different studies, the drug has demonstrated its ability to reduce “off” time for patients taking levodopa, as well as a reduced rate of dyskinesia. The drug works by targeting an enzyme that breaks down dopamine in the brain, allowing for better results from levodopa in controlling motor functions.
“We are delighted with the approval of Xadago in the USA. This first new treatment for a decade represents an important addition to the treatment choices for patients with PD and their doctors. In order to more fully characterize the clinical benefits of Xadago, Zambon will continue to work with our partners on new clinical trials,” said Charlotte Keywood, global head of R&D for Zambon.