Croma submits toxin for European approval

Austrian medical aesthetics company Croma Pharma has submitted its licensed Korean toxin product to The Federal Institute for Drugs and Medical Devices in Germany (BfArM) for approval. 

Croma licensed its botulinum toxin product from Korean toxin manufacturer Hugel and established a joint-venture company in 2018. 

The filing to BfArM marks the first step in Croma’s approach to a European-wide regulatory approval. 

The submission in Europe is based on two completed randomised, placebo-controlled Phase III pivotal trials (BLESS I and II) that enrolled a total of 917 subjects in Europe and the US. 

A third confirmatory pivotal trial to support the US submission (BLESS III) is currently ongoing in sites in Europe and the US and has completed its interim analysis after all 355 patients completed their visits for the primary endpoint.

Croma chief executive Andreas Prinz commented: “We are pleased to announce that our toxin has finally been submitted – since quite some time hence, a European company will launch a botulinum toxin, which makes us both, happy and proud. 

“Combining our present product and service offering with the last ‘missing link’ will definitely boost our business and will have a feelable impact not only on our marketing and sales approach, but for sure also on our corporate culture.”

Croma also manufacturers a HA filler range, PDO threads, PRP and cosmeceutical skincare products. 

The International Trade Commision in the US sided with Allergan over ongoing rival toxin dispute.