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Originally Posted by ashleyk
I noticed that there are many phase 1 and 2 trials but few phase 3. And application to market a new drug seems to go nowhere with the FDA. Maybe they know what they are doing or maybe they see no urgency to do anything.
In any event there seems to be a drug in phase 3 for advanced PD which seems very helpful for quality of life, safinamide. Is this study going to be put on the shelf or fast tracked by the FDA? People with 10 or more years of PD are running out of time.
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ashleyk, I don't think Newron Pharmaceuticals, the manufacturer of Safinamide, has any intention of "shelving" the drug. In fact, they have already submitted a Marketing Authorization Application (MAA), to the European Medicines Agency (EMA). Newron is an Italian company so this makes sense. Although I am not aware of their having received a US FDA fast-track designation, the company has stated that they hope to have an NDA filed with the FDA late first quarter or early second quarter of 2014. In their pre-NDA meeting, the FDA did not request any further clinical studies on the drug, which is very positive. Therefore, I would think this drug goes thru the approval process with the MAA and FDA rather "quickly" (which is just a relative term for people who are desperately waiting for something new). The results of the Phase III studies were very positive (significant efficacy and good safety profile), so I think the industry is looking for the drug to be approved by all agencies.