CHMP nod for Chiesi's Holoclar, Europe's first stem cell therapy
This article was originally published in Scrip
Executive Summary
The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended a conditional regulatory approval for Chiesi's Holoclar for moderate to severe limbal stem cell deficiency (LSCD) due to ocular burns. The orphan drug is the first stem cell therapy to be recommended for approval in Europe.