Nusinersen

2024: Drug registration

On April 23, 2024, it became known that it Ministry of Health Russia had registered a domestic analogue of the drug spinraza (international non-proprietary name - nusinersen), which is one of the most expensive drugs in the world. This agent is intended for therapy - spinal muscular atrophy (SMA) a hereditary disease characterized by the development of progressive muscle weakness.

Nusinersen is a pathogenetic therapy for all types of SMA. It increases the production of motor neuron survival protein, impeding disease progression and contributing to stabilizing the condition and/or improving the motor function of patients.

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According to the Vedomosti newspaper, the domestic drug will enter the market under the name lantesense. Information about it is entered in the State Register of Medicines (GRLS). The drug will be produced by the biotechnological company Generium, which during the peak of the COVID-19 pandemic was one of the largest manufacturers of the Sputnik V vaccine.

The manufacturer of spinraza is the American company Biogen: the cost of the drug in Russia as of April 2024 is approximately 5.13 million rubles per package. Representatives of Generium said that the domestic analogue of the drug will be cheaper, but how much is not specified. Nikolai Bespalov, Development Director of the analytical company RNC Pharma, believes that the price of lantesense may be 15% lower compared to Biogen.

It is noted that nusinersen is included in the list of vital drugs and the prices for it are regulated by the state. General Director of Generium Daniil Talyansky said that the company was the first in the world to reproduce nusinersen. The release of the drug in Russia will make it available to more patients in need. The drug will be fully produced at the Generium site in the Vladimir region.^[1]

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