According to Vademecum, Russia has granted EAEU registration to Luxturna (voretigene neparvovec), a drug intended for the treatment of hereditary retinal dystrophy. The developer of the drug is the US-based Spark Therapeutics, and the holder of the license is the Swiss Novartis (responsible for the distribution of the drug outside the United States).
In 2017, the US Food and Drug Administration (FDA) approved Luxturna for the treatment of biallelic RPE65 mutation-associated retinal dystrophy. The cost of treatment for both eyes in the USA is $850,000. Spark Therapeutics and Novartis signed an agreement in early 2018, according to which the Swiss pharmaceutical company received the rights to sell the drug outside the United States. A few months later, the use of Luxturna for the same indication was approved by the European Medicines Agency (EMA).
In the summer of 2021, hereditary retinal dystrophy was included in the list of diseases for which the Circle of Kindness, a state foundation, procures therapies. Last September, the Board of Trustees of the Foundation approved the purchase of Luxturna as an unregistered drug. In November, the Circle of Kindness signed a contract with the pharmaceutical company Irwin 2 (part of Pharmeco) and Helmholtz Moscow Research Institute of Eye Diseases for the supply of Luxturna for six wards of the Foundation.
On December 9, 2021, Russia registered Novartis’s Zolgensma (onasemnogene abeparvovec), a treatment for spinal muscular atrophy (SMA).
