Almirall Completes Decentralized Regulatory Approval Procedure for Efinaconazole in Europe

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Almirall announced today the successful completion of the decentralized regulatory procedure for efinaconazole in Europe. This triazole antifungal compound, marketed as Jublia, is specifically indicated for the treatment of onychomycosis, a condition affecting approximately 5.5% of the global population and accounting for 50% of nail disorder consultations, according to a release from the company.¹

Onychomycosis is a persistent and often difficult-to-treat fungal infection of the nails. Low treatment success rates are common, primarily due to challenges in long-term adherence to therapies. Almirall said in the release that efinaconazole's unique formulation offers a high nail-penetrating capability with a low binding affinity to keratin, enhancing its efficacy in targeting fungal infections within the nail.

Recent Research Insights

Recent in vitro experiments presented at the Maui Derm Hawaii 2024 conference further highlighted the efficacy of efinaconazole. This study compared the penetration efficiency of various topical antifungals through keratin-free cellulose disks versus human toenails, revealing that efinaconazole demonstrated superior transungual penetration and antifungal activity against Trichophyton rubrum and T. mentagrophytes. Specifically, efinaconazole exhibited the greatest average zone of inhibition ZI of 82.1 mm against T. rubrum, outperforming other FDA-approved treatments like ciclopirox and tavaborole. The findings suggested that the lower keratin binding of efinaconazole contributes significantly to its enhanced efficacy, making it a compelling option for managing onychomycosis.²

"Among all antifungals tested, ability to penetrate human toenails and inhibit growth of both T. rubrum and T. mentagrophytes was greatest for efinaconazole, followed by tavaborole," wrote study authors Elabbasi et al at the time of publicatitn. "These results indicate superior transungual penetration of efinaconazole compared to the other antifungals, perhaps due to lower keratin binding in the nail."

Regulatory Progress

The company said this completion of the decentralized regulatory procedure marks a significant milestone for efinaconazole in Europe, paving the way for national marketing authorizations the company anticipates by H1 2025.

“At Almirall, we are dedicated to medical dermatology, and to addressing unmet needs of people living with skin conditions such as persistent and difficult to treat nail infections,”Almirall executive vice president of research and development and CSO Dr. Karl Ziegelbauer, PhD, said in the release. “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. 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.”

Following a licensing agreement in July 2021, Almirall obtained exclusive rights for the development and commercialization of efinaconazole in Europe. The compound has been marketed in Japan since 2014 under the trade name Clenafin, and is already available in the United States and several other regions as Jublia.

Conclusion

In the release, Almirall said that this introduction of efinaconazole represents a promising advancement in the treatment landscape for onychomycosis. As regulatory processes advance, they said dermatologists can anticipate the availability of this innovative topical therapy, which is poised to enhance treatment outcomes for patients struggling with this challenging condition.

References

1. Almirall announces completion of decentralized regulatory approval procedure for efinaconazole in Europe. News Release. Almirall. Published October 15, 2024. Accessed October 15, 2024. https://www.almirall.com/newsroom/news/almirall-announces-completion-of-decentralized-regulatory-approval-procedure-for-efinaconazole-in-europe
2. Andrus E. Efinaconazole demonstrates superior transungual penetration compared to other antifungal treatments. Dermatology Times. Published January 29, 2024. Accessed October 15, 2024. https://www.dermatologytimes.com/view/efinaconazole-demonstrates-superior-transungual-penetration-compared-to-other-antifungal-treatments