Pharmaceuticals and Medical Devices Agency (PMDA) has received a Japanese new drug application (J-NDA) from Amicus Therapeutics, Inc (NASDAQ:FOLD).This global biotechnology industry leader made its submission in a bid to seek out a marketing authorization for migalastat, which happens to be a precision medicine for Fabry disease.
The Chief Executive Officer of Amicus Therapeutics, Inc while speaking to journalists recently said, “On the heels of our initial commercial launch success for migalastat in the EU, we are pleased to submit our Japanese new drug application for migalastat. With more than 700 Fabry patients currently treated in Japan, we believe that a substantial number of Japanese Fabry patients could potentially benefit from migalastat as a differentiated precision oral therapy with a unique mechanism of action.”
This top executive outlined that Japan remained an important part of the company’s patient-focused vision looking out for mechanisms that will cater for the provision of migalastat to amenable Fabry patients globally. He added that they were optimistic that their collaboration with the PMDA toward a potential approval would go through. It would mark a new beginning for them towards achieving immense business success.
A meeting was held previously, and one thing that came out clearly was the fact that J-NDA had much to do with the data associated with the completed clinical studies with migalastat. According to Yahoo, migalastat may be receiving a lot of positive reviews in future. The other thing is that it might also be receiving about 10 years of market exclusivity provided the responsible body moves ahead to approve it.
The first half of 2018 may witness PMDA release the much anticipated decision. Amicus remains positive that indeed matters will play out in its favor and from there it hopes to make its next move. Just like any other top provider, it will be looking at all possibilities to expands its market and generate high revenuers.
At the moment, not much can be said in relation to the matter. We just have to wait and see.