The Russian Ministry of Health has granted the Russian pharmaceutical company Amedart permission to conduct a comparative clinical trial on the bioavailability and bioequivalence of a generic version of the orphan drug Koselugo (selumetinib), which was originally developed by the Anglo-Swedish pharmaceutical company AstraZeneca. The information appeared in the State Register of Medicines. This drug is intended to treat neurofibromatosis type 1 in children.
The trials of the reference drug will be carried out at the Tomsk National Research Medical Center of the Russian Academy of Sciences. The study will involve 40 healthy volunteers, and the completion of the clinical trial is scheduled for the end of 2027.
Selumetinib is the world’s first drug approved for treating plexiform neurofibromas in children with neurofibromatosis type 1. Koselugo is the only drug in Russia with this active ingredient.
AstraZeneca has received approval from the Ministry of Health for registration at the end of 2021. The Circle of Kindness Charitable State Foundation first purchased the drug in early 2022. In 2024, the Medical Support Center conducted at least 10 large procurement procedures totaling 5.7 billion rubles.
Neurofibromatosis type 1 (NF1), also known as Recklinghausen’s disease, is a genetic disease characterized by the development of tumors on nerve tissue and on the skin, as well as other symptoms such as café-au-lait spots and bone abnormalities. This is one of the most common hereditary diseases.
