Almirall completes first phase of efinaconazole regulatory approval in Europe

Key takeaways:

• Efinaconazole is indicated for the treatment of onychomycosis, a nail fungal disease.
• The completion of the decentralized regulatory procedure makes way for national marketing authorizations.

Almirall has completed the decentralized regulatory procedure in Europe for efinaconazole for the treatment of onychomycosis, the company announced in a press release.

Onychomycosis, a fungal infection of the nail, affects about 5.5% of the world and can be very persistent and difficult to treat. Efinaconazole is a triazole antifungal topical that binds to keratin to deeply penetrate into onychomycosis-affected nails.

“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,” Karl Ziegelbauer, PhD, vice president of R&D and chief scientific officer of Almirall, said in the 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.”

With the decentralized procedure now being complete, Almirall can pursue national marketing authorizations which are expected in the first half of 2025. Efinaconazole will be marketed under the trade name Jublia in Europe.