Almirall initiates decentralised procedure for fungal nail treatment

Almirall S.A. a global biopharmaceutical company focused on skin health, announced the filing for the regulatory submission for efinaconazole, a triazole antifungal compound indicated for the treatment of mild-to-moderate fungal infection of the nail in adults and children (aged 6 years and older) in Germany and Italy under the European decentralised procedure.

The German regulatory authority is acting as Reference Member State.

The successful completion of a decentralised procedure is the prior step before national marketing authorisations can be granted by the European countries and the outcome of the regulatory filing is expected to be known around the third quarter of 2023.

This submission follows the agreement with Kaken Pharmaceutical Co. Ltd. on 1 July 2021 to proceed with the marketing authorisation of efinaconazole in European countries. The product has been marketed in Japan since 2014 under the trade name of Clenafin. It has also been launched in the United States, Canada, Korea, Taiwan, Hong Kong and Macau by Kaken Pharmaceutical’s partner companies under the trade name of Jublia. 

Global prevalence of onychomycosis is estimated to be around 5.5% and the condition is responsible for 50% of all consultations for nail disorders. The active principle of efinaconazole, a triazole antifungal compound discovered by Kaken Pharmaceutical, is indicated for the treatment of onychomycosis, a fungal infection of the nail. Since it has low binding affinity with keratin, the main component of nails, it has nail-penetrating properties. 

“We are pleased to have submitted the application for efinaconazole on schedule. Existing data suggest that the addition of this product to the European market will enhance the treatment options for onychomycosis and thus improve the quality of life of patients,” stated Karl Ziegelbauer, Ph.D., Almirall S.A.’s chief scientific officer. 

“This milestone demonstrates Almirall's dedication to offering innovative treatments to patients for a range of dermatological diseases and the good progress of our pipeline. We look forward to continuing this positive momentum in the rest of the year and to further unlocking its great potential.”