Amicus Therapeutics, Inc. (FOLD) announced that it completed an End of Phase 2 meeting with the U.S. Food and Drug Administration for Amigal in Fabry Disease.
The FDA specified that the data from the completed Phase 2 clinical studies of Amigal support the start of Phase 3 development and agreed that Amigal meets the criteria to be considered for accelerated approval.
The company said that the meeting followed the successful conduct of Phase 2 clinical studies in patients with Fabry disease that showed Amigal was generally safe and well-tolerated at all doses evaluated. In a majority of patients, treatment with Amigal resulted in increased activity of the enzyme deficient in Fabry patients and a reduction of kidney GL-3 as measured in urine.
Amicus said that, along with its partner Shire Human Genetic Therapies, Inc., it is engaged in ongoing discussions with the FDA and the European Medicines Agency regarding plans for a global Phase 3 clinical development program for Amigal.
Amicus noted that in line with previous guidance, it expects to complete the interactions in the second half of 2008, and subject to the outcome of the discussions, the company plans to initiate Phase 3 development of Amigal in the first half of 2009.
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