Klaria submits Marketing Authorization Application for Sumatriptan Alginate Film in Europe
UPPSALA — November 29, 2022 — Klaria Pharma AB (publ) (Nasdaq Stockholm: KLAR) today announces that the Company has submitted a Marketing Authorization Application (MAA) for Sumatriptan Alginate Film for the treatment of Migraine in the European Union. Pending positive validation, Sumatriptan Alginate Film will be subject to a regulatory assessment according to the standard timeline, which would result in approval in Q1, 2024.
“Sumatriptan Alginate Film addresses an important medical need in patients with migraine. With the submission of the MAA, we have now successfully done everything we can do to bring this medicine to migraine patients in Europe. This is also an important achievement for Klaria as a company, we are seeking approval for our first product. Reaching this major milestone is the direct result of the dedicated work of the Klaria team”, says Jesper Wiklund, CEO of Klaria. “In addition, I would like to express sincere gratitude to all patients, investigators, collaborators and shareholders who have brought us to this point and help make this possible”.
The MAA has been submitted to the medical regulatory body in Germany (BfArM) in a decentralized procedure. BfArM is the national competent authority responsible for the authorization of Sumatriptan Alginate Film in the European Union. The MAA has also been submitted to the regulatory authorities in Spain and Italy.
About Sumatriptan Alginate Film:
Sumatriptan Alginate Film (SAF) is a new product designed to address a key unmet medical need in the treatment of migraine, designed with the particular issues of migraine patient experiencing a migraine attack. SAF is bioequivalent to the nasal spray and thus will be considered a direct replacement of the nasal spray, and can also be used instead of tablets or injections. Sumatriptan Alginate Film is patent protected by both the technology patent and the product-specific patent in the relevant markets. SAF is an alginate-based oral trans-mucosal film and it is the first oral trans-mucosal migraine product and is designed to be a significant improvement to all available acute migraine treatments available to patients today, particularly in patients suffering from migraine-induced nausea and vomiting. SAF is also particularly suited for the treatment of migraine in pediatric populations. SAF is a unique molecular dispersion of the active antimigraine drug sumatriptan. The uniqueness and promise of the Sumatriptan Alginate Film has been confirmed by the project being awarded the exclusive European Commission Horizon 2020 Innovation Grant in 2018 (Grant Number 8296159).