As of January 25, aesthetic manufacturer Croma-Pharma has confirmed completion of the decentralised procedure for its new botulinum toxin.
According to the company, the next step is to gain local market authorisation for Letybo Europe across all territories.
The toxin has been indicated for the treatment of moderate to severe glabellar lines.
The submission in Europe is based on the data of three completed, randomised, placebo-controlled phase three trials which enrolled a total of more than 1,000 subjects in Europe and the US, explains Croma.
Croma has licensed the product from the Korean toxin producer Hugel Inc for Europe and established a joint venture company in 2018 with Hugal Inc in order to develop and commercialise its hyaluronic acid dermal filler products with Hugel’s botulinum toxin product in the US, Canada, Australia and New Zealand, notes the company.
Andreas Prinz, managing director at Croma-Pharma, said, “We are pleased to announce that our toxin has now completed 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.”
