Almirall finalizes EU approval for antifungal Jublia

Almirall has successfully concluded the European regulatory procedure for efinaconazole, known under the trade name Jublia, aimed at treating onychomycosis, a persistent fungal infection of the nails. This milestone marks a significant advancement in Almirall’s medical dermatology portfolio across Europe and is the final step before individual European countries can issue national marketing authorizations for the drug.

Onychomycosis is a widespread condition, affecting approximately 5.5% of the global population. It represents half of all nail disorder consultations and is notoriously difficult to treat effectively. One of the key features of efinaconazole is its low binding affinity to keratin, a crucial component of nails. This property allows the drug to penetrate the nails more effectively, making it a potent treatment for the stubborn infection.

Almirall began the regulatory submission process for efinaconazole in May 2022, targeting Germany and Italy through the European decentralised procedure. The German regulatory authority served as the reference member state for this process.

Dr. Karl Ziegelbauer, Almirall's Chief Scientific Officer and Executive Vice-President for Research and Development, highlighted the importance of this achievement. He stated that the completion of the decentralised regulatory procedure paves the way for European countries to approve efinaconazole as an advanced treatment option for onychomycosis. He noted that the topical treatment is a valuable addition to Almirall’s expanding portfolio for this condition, and expressed enthusiasm about providing it to European dermatologists and their patients in the near future.

Almirall acquired exclusive development and marketing rights for efinaconazole in Europe from Kaken Pharmaceutical in July 2021. This agreement included an upfront cash payment to Kaken, as well as milestone payments and royalties based on the net sales of the product. Efinaconazole is already available in the US, Canada, Korea, Hong Kong, and Macau, and has been marketed in Japan under the name Clenafin since 2014.

Almirall is currently working closely with national regulatory authorities, with the expectation of receiving marketing authorizations in the first half of 2025. This collaboration is a crucial step in making efinaconazole available to a broader patient population across Europe.

In another strategic move, Almirall entered into a collaboration with Microsoft in February 2024 to enhance drug development in dermatology, reflecting the company’s commitment to leveraging advanced technology and partnerships to advance medical treatments.

Efinaconazole’s ability to effectively penetrate the nail and treat onychomycosis promises to be a game-changer for patients suffering from this persistent and often treatment-resistant condition. With the completion of the necessary regulatory steps, Almirall is poised to offer this advanced therapeutic option to the European market, marking a significant step forward in the management of nail fungal infections.