Amicus Therapeutics, Inc. (NASDAQ:FOLD) announced the initiation of a reimbursed EAP (expanded access program) to ensure that all the Fabry patients having amenable mutations can have proper access to migalastat. Amicus is a leading biotechnology company, famous for its world-class therapies for the orphan and rare diseases.
As per the reports, Amicus will implement EAP in certain territories where it can be assured of reimbursement’s security before the start of marketing activities and commercial deployment. France is the first country where EAP will be implemented.
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As of now, everything is going as per the schedule. The French National Agency for Medicines and Health Products Safety has already authorized it to sell migalastat by issuing “Autorisation Temporaire d’Utilisation dite de cohorte.” It depicts that migalastat can be sold to Fabry patients having genetic mutations and meet the specified criteria for cohort ATU. Reports claim that ATU is nothing but a regulatory mechanism used by ANSM to develop non-approved drugs for French patients whenever a genuine need arises.
The senior management team of Amicus is delighted to announce this update and hopes that things will continue to improve in the coming months. According to John F. Crowley, CEO & Chairman, Amicus Therapeutics, the primary mission of the company is to ensure that patients have full access to migalastat. Amicus will look forward to making it available in those territories where a mechanism to secure reimbursement is available prior final approval.
The French government has already given green signal to Amicus, for which the entire senior management team is grateful. Going forward, Amicus will continue to work hard to improve its offerings and expand the reach of migalastat, so that more and more patients can be benefitted. More information about the future initiatives will be announced from time to time and shared with shareholders via online and offline resources.