After having undergone the necessary meetings with the Europe and the U.S. regulators, Amicus Therapeutics, Inc. (NASDAQ:FOLD) has made up its mind to seek accelerated approval for its drug named migalastat. The company is seeking approval for this drug that in turn will be used for experimental treatment of the rare genetically inherited ailment called Fabry.
Reason for seeking accelerated approval
In case, Amicus gets success in getting this accelerated approval by the EU and the U.S., it will become the first company to have the oral treatment for Fabry disease, a rare medical condition. As of now, there is just the availability of an intravenous treatment for this disease, and it is called Fabrazyme. This treatment is made by Genzyme Corporation. Also, if successful, this treatment will allow the company to generate good amount of revenues.
Usually when FDA or other regulatory bodies give a green signal to the drug for treatments, they have certain stringent criterion for the passing stages. However, in case of accelerated approval, less strict criteria are followed.
The designation of accelerated approval for drugs that are targeting serious and fatal conditions is given by the FDA. At times, this U.S. regulatory body uses the designation for reviewing those drugs which stand up to a medical need that is still unmet.
The trials of drug undergoing already
Amicus is planning to file approval for migalastat with the U.S. Food and Drug Administration after June 2015. In the Europe, it is looking for the approval in the second fiscal quarter. In its later stages of the study, the probable therapy for the aforesaid disease has shown optimistic results.
Fabry is the kind of inherited disease, in which, a certain of fat accumulates and builds-up in the cells of a human body. This in turn leads to cardiovascular, kidney and skin ailments, and also causes pain.