Posted by Michael Wonder on 06 Jun 2018
Audentes announces PRIME designation granted by the EMA to AT132 for the treatment of X-linked myotubular myopathy
5 June 2018 - Audentes Therapeutics today announced that the EMA has granted PRIME designation to AT132 for the treatment of X-linked myotubular myopathy.
The PRIME designation is intended to enhance interaction and early dialogue with developers of promising therapies to optimize development plans and speed evaluation so that these medicines may reach patients as early as possible.
"We are pleased that AT132 has been accepted into the PRIME program, which is analogous to the Breakthrough Therapy and Regenerative Medicine and Advanced Therapy designations from the U.S. Food and Drug Administration," stated Mary S. Newman, Senior Vice President, Regulatory Affairs. "This PRIME designation has been enabled by the positive interim data reported from the first dose cohort of ASPIRO, the Phase 1 / 2 clinical trial of AT132, and we look forward to collaborating with the EMA to accelerate the clinical development of this potentially transformative therapy for XLMTM patients."
