Zolgensma

2021: Registration of the drug in Russia

In December 2021, the Ministry of Health of the Russian Federation registered the drug Zolgensma, which is used to treat spinal muscular atrophy (SMA) in children.  This medicine worth about $2.1-2.5 million is considered the most expensive in the world.

Olga Germanenko, head of the SMA Family Foundation , told  Novaya Gazeta that usually from the moment the drug is registered until it enters civil circulation, it takes about two to six months. According to her, during this period the availability of the drug decreases, because  it needs to be imported in Russian packaging, and it takes time to create and compile instructions in accordance with Russian labeling.

In Russia, registered the most expensive medicine in the world - the drug "Zolgensma," which is used to treat spinal muscular atrophy in children

During this period, it is impossible to import the drug, as it was done before, before registration, in international packaging, "she explained.

Zolgensma is manufactured by the Swiss company AveXis: it filed an application for registration of the drug in Russia in July 2020. Prior to this, two more CMA drugs were registered in the country - Spinraza and Eurysdi (risdiplam). They  need  to continue their treatment all their lives, and in the case of Zolgensma, a single injection under the age of two is enough.

The price of other medicines for AGR is less, but they are also  expensive: the cost of Spinraza (registered in Russia in August 2019 ) is $750 thousand in the first year of treatment, $375 thousand  in subsequent years. The cost of Risdiplam  is $340 thousand per year.

CMA is a group of inherited diseases that occur with damage or loss of motor neurons of the spinal cord, which leads to the progressive development of muscle atrophy, including breathing. It is one of the most common causes of child mortality caused by hereditary diseases. The cause is a mutation of the SMN1 gene.

In Russia, the drug "Zolgensma" is purchased through the fund for helping children with rare diseases "Circle of Good." Purchases went even despite the fact that there was no registration of the drug before.^[1]

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