After an odyssey of setbacks, FDA finally green-lights Newron’s Parkinson’s drug Xadago

For Italy’s Newron, persistence has finally paid off. After following two radically different paths to get its add-on therapy safinamide on the market in Europe and the US, the FDA has finally offered a green light for their Parkinson’s drug safinamide after seven years of trial and error.

While the company submitted an MAA in Europe in 2013, setting them on a path to approval on the continent in early 2015, the FDA refused to even accept their first application in 2014, faulting them for a series of mistakes in the NDA. A rejection followed their first accepted filing, with concerns about potential abuse of the drug that needed to be addressed first.

All of that occurred after Merck Serono dropped their partnership on the drug in 2011, after deciding they weren’t bullish on its commercial prospects. And then BioTie in Finland punted a deal to acquire the company for $63 million in stock.

Today, though, Newron and its new partners, Zambon and US WorldMeds, had cause for celebration. Safinamide will now be sold as Xadago by US WorldMeds, which did a deal with Zambon for the commercial rights.

The drug is a selective MAO-B inhibitor and has demonstrated in two studies 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.

Charlotte Keywood, global head of R&D for Zambon, said:

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.

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