CHMP Recommends Approval of Xadago™ (Safinamide) to Treat Parkinson´s Disease in EU
 

http://www.prnewswire.com/news-relea...286334911.html

http://www.reuters.com/article/2014/...0U32MR20141219

waiting . . .
 

Any idea how long this might customarily take to get FDA approval? Seems like a perfect mission for the MJFox Foundation.

Newron submitted their NDA for Safinamide to the FDA this past May. The normal time period for approval, assuming everything goes ok, would be about 12 months. So, they are expecting to receive FDA approval sometime in mid-2015. As the data of the last two studies was very favorable, there has been extensive testing over the past few years, and the EU approval is imminent, I am expecting this to move smoothly through the FDA review process. I don't see what MJFF could do at this time as it is already well into FDA review.

update
 

As a result of file organizational problems, the FDA sent Neuron a Refusal to File (RTA) letter with regard to their initial NDA filing in May. Newron announced today that the NDA for Safinamide has been re-submitted to the FDA. This follows the announcement last week that the CHMP has given a positive opinion on safinamide for Europe. It really is amazing that it takes 6 months for the FDA to reject a submittal and for the company to then resubmit. Just another reason for the unbearable timeline involved in getting a new drug approval.

http://www.cnbc.com/id/102298175