Novartis will register in Russia medication for the treatment of SMA
In mid-July, Novartis filed with the Ministry of health dossiers for registration of drug gene therapy nazemnogo ibuprofen (trade name — Solvency), designed to treat spinal muscular atrophy (SMA). If approved Solvency will be the first gene therapy drug is registered in Russia, the Fund reported “Families of SMA”.
In case of successful registration on the territory of RF drug nazemnogo ibuprofen (Solvency) is indicated for the treatment of patients with spinal muscular atrophy (SMA) with bi-allelic mutation in the gene SMN1 and a clinical diagnosis of SMA 1-type, as well as patients with SMA with bi-allelic mutation in the gene SMN1 that have up to 3 copies of the gene SMN2, inclusive, including patients without clinical appearances.
To date, drug treatment Zolgensma received 13 patients from the Russian program pre-access. Each case is individual, so questions regarding the prescription and use of drug therapy should be addressed first of all to the attending physician of the patient. The importation of drugs into the territory of the Russian Federation can be carried out for health reasons for specific patients in compliance with the requirements defined by the Federal law No. 61 – F3 “On circulation of medicines”.