Santhera Update on Pre-NDA Meeting with FDA
News Jun 16, 2015
Santhera Pharmaceuticals has announced that it has discussed its plans to submit a New Drug Application (NDA) for Raxone®/Catena® (idebenone) in DMD with the US FDA in a pre-NDA meeting.
The Agency and Santhera agreed that data presented at the meeting, including natural history data obtained under collaboration with the Cooperative International Neuromuscular Research Group (CINRG), and the possible implications of the natural history data on plans for this NDA will be further discussed during a second meeting.
"In our meeting with the FDA, we also communicated that we have recently started a collaboration with CINRG to compare the outcomes of the successful Phase III DELOS trial with a comprehensive data-set collected by CINRG in their Duchenne Natural History Study over the past years. We are confident that these comparative analyses will further support the clinical relevance of the DELOS trial results which showed a clinical benefit on respiratory function in patients not taking concomitant glucocorticoid steroids. Our Fast Track designation allows us regular interactions with the FDA, and we will now prepare for a second meeting with the Agency to discuss our plans for submitting an NDA in light of these emerging data," stated Thomas Meier, PhD, CEO of Santhera. "In parallel to these ongoing activities, we are continuing to prepare the NDA for submission."
Idebenone has been granted orphan drug designation for DMD in Europe and the US and has use patent protection until 2026 in Europe and 2027 in the US. The FDA recently granted Fast Track designation for Raxone/Catena (idebenone) for the treatment of DMD.