US FDA briefs: fast-track for Zeltia's Zentylor; OK for Baxter's Protopam; warning on gadolinium-based contrast agents

13 September 2010

Noscira, a Spanish firm Grupo Zeltia (ZEL: MC) subsidiary specialized in R&D drugs to treat neurodegenerative diseases, has been granted US Food and Drug Administration fast track status for its neuroprotector drug Zentylor (tideglusib) to treat progressive supranuclear palsy (PSP), a fast-advancing fatal degenerative brain disorder. A Phase II trial with tideglusib in PSP commenced in December 2009 and is currently in progress.

On November 11, 2009, Noscira announced that the FDA and the European Union had granted tideglusib orphan drug status for treating PSP, for which there are currently no treatment options. Zentylor is the only GSK-3 inhibitor in clinical development for PSP, according to the company.

Pediatric use of Protopam for chemical poisoning treatment cleared

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