Newron back on track for Xadago approval in US

September 9, 2016

Italian firm is not required to conduct additional trials for its Parkinson’s disease drug

Newron Pharma will not have to conduct any additional clinical trials for its Parkinson's disease drug Xadago in the US, setting up a new FDA filing in the coming weeks.

The Italian pharma company's partner Zambon is already rolling Xadago (safinamide) out in Europe following its EMA approval last year, and has just launched in Norway taking the tally of countries where it is available to 11.

However, hopes of a US launch hit a major setback in March when the FDA rejected its marketing application with a request for more information on its abuse potential.

Now, Newron is planning to refile a marketing application with the FDA in November, setting Xadago on course for a mid-2017 approval in the world's largest pharma market, where privately-held Zambon has sub-licensed it to specialty pharma firm WorldMeds.

Analysts at Edison had placed a hold rating on the company on fears that the FDA would demand additional clinical trials, but now predict the drug will be used in around 10% of all Parkinson's disease patients six years after launch - which would represent a market of around €450m a year.

The monoamine oxidase type B inhibitor is used as an add-on to levodopa therapy - the mainstay of Parkinson's disease treatment - and competes with Lundbeck and Teva's Azilect (rasagiline), which had sales of around $650m in 2014 but is due to lose patent protection next year.

Edison suggests Xadago may be insulated from generic competition somewhat as it does not appear to have a tyramine interaction, which means users do not have to adopt dietary restrictions such as avoiding cheese and red wine.

They also note that in trials Xadago has shown positive effects on dyskinesia - involuntary movements such as tics that can develop after prolonged levodopa use in Parkinson's - that could represent an additional €350m market opportunity for the drug.

"We assume the safinamide label could be expanded to include dyskinesia following a single clinical trial, which could potentially start once approval has been granted in the US and could lead to potential launch in 2020," say the analysts.

http://www.pmlive.com/pharma_news/newron_back_on_track_for_xadago_approval_in_us_1126516?