Croma-Pharma completed decentralised procedure for new toxin

Croma-Pharma (Croma) has announced that the decentralised procedure for its botulinum toxin to gain market authorization in Europe has been accomplished.

This important step is the basis to complete Croma’s already comprehensive portfolio. 

Croma’s botulinum toxin submission in Europe is based on the data of three completed randomised, placebo-controlled phase III trials that enrolled a total of >1000 subjects in Europe and the US. National phases to grant the market authorization across Europe are following now.

By adding its own botulinum toxin to the already broad portfolio, Croma catapults itself to a new level within the aesthetic industry.

“We are pleased to announce that our toxin has now accomplished the decentralised procedure in Europe and will continue with the market authorisation in major European countries in the next months. With this, we will now be able to complete our portfolio to meet all the needs of our customers”, managing director Andreas Prinz said.

Croma has licensed the product from the Korean toxin producer Hugel for Europe and established a joint venture company in 2018 with Hugel in order to develop and commercialise Croma’s HA filler products together with Hugel’s botulinum toxin product in the US, Canada, Australia and New Zealand. Hugel’s botulinum toxin has been the number one toxin in South Korea for six years.

REFERENCE

1. Mueller D, Sulovsky M, Prinz V, Cajkovsky M, Frank K. Efficacy and Safety of a Novel Neurotoxin (Letibotulinum Toxin) in the Treatment of Glabellar Lines - 3 Randomised, Double-blind, Placebo-Controlled Studies Followed by Open-label Extensions. Abstract published at 19th Aesthetic & Anti-Aging Medicine World Congress-AMWC; 2021 Sept 16-19; Monaco.