European Decentralized Regulatory Procedure Completed for Efinaconazole

Almirall, S.A. announced the successful completion of the decentralized regulatory procedure in Europe for efinaconazole, a triazole antifungal compound indicated for the treatment of onychomycosis, under the trade name of Jublia®.

The low binding affinity of efinaconazole topical to keratin, the main component of nails, allows high nail-penetrating properties supporting strong efficacy.

“The completion of the decentralized regulatory procedure for efinaconazole in Europe enables European countries to approve this advanced treatment option to support people with onychomycosis,” Almirall executive VP of R&D and CSO Dr. Karl Ziegelbauer said in a press release. “Efinaconazole as a topical treatment is a valuable addition to our expanding onychomycosis portfolio and we are looking forward to being able to offer it to European dermatologists and their patients in the near future.”

In July 2021, Kaken and Almirall entered into a license and distribution agreement, granting Almirall the exclusive rights for the development and commercialization of this topical formulation in Europe. The product has been marketed in Japan since 2014 under the trade name Clenafin®. It has also been launched in the United States, Canada, Korea, Hong Kong, and Macau by Kaken Pharmaceutical’s partner companies under the trade name Jublia®.

The successful completion of the decentralized procedure is the final step before national marketing authorizations can be granted by European countries. Work with the national regulatory authorities is now underway, and marketing authorizations are expected within H1 2025.