PSK Pharma has announced the release of a new domestic drug Sevelamer (Sevella) for the treatment of chronic kidney disease (CKD). The drug is included in the list of vital and essential drugs (VED) approved by the Government of the Russian Federation.
Chronic kidney disease is a slowly progressive (months to years) decline in the kidneys’ ability to filter metabolic waste products from the blood, or a decrease in renal function. The danger of the disease is that renal insufficiency may not have clinical manifestations as lon as up to its critical, fifth stage. A person may be experiencing no symptoms even after the death of 70% of nephrons.
According to international studies, up to 27 million people in Russia suffer from CKD, but just over 10% know about their diagnosis. The disease is nearly as prevalent as such socially significant diseases as hypertension, diabetes, and obesity. Signs of kidney damage and/or a decrease in the glomerular filtration rate are detected in at least ten percent of the population.
Before the disease has reached the stage when dialysis is required, doctors recommend using calcium-containing drugs for the treatment of hyperphosphatemia, such as sevelamer, especially in combination with the proper diet and exclusion of calcium-containing dietary supplements. In absolute terms, sevelamer is able to halve the risk of death from all causes during the follow-up period compared with drugs for the treatment of hyperphosphatemia, which contain calcium.
The first foreign sevelamer drug appeared in Russia only in 2008, and until September 2022 there was no completely Russian-made analogues on the domestic market. PSK Pharma has received a registration certificate for the production, packaging and release control of Sevella, film-coated tablets containing 800 mg of sevelamer each.
Since 2016, PSK Pharma has been producing medicines for the treatment of serious diseases as part of import substitution. In March 2022, the company announced that its workshop for chemical substances required for full-cycle production of domestic medicines was ready for operation.
By the end of the year, PSK Pharma plans to start production of 20 chemical substances, and next year it is launching a site for the production of biological substances for biotechnological drugs. This step will provide the necessary raw materials for the company’s production amids economic sanctions, as well as reduce import dependence and increase the availability of drugs for Russians.
“We are pleased to announce that a new completely domestic drug Sevella for the treatment of chronic kidney disease has become available to Russia’s residents. Uninterrupted provision of patients with highly effective drugs is one of PSK Pharma’s key values, which is why we have been working hard for several years to overcome the import dependence of the Russian pharma market. We continue to invest in expanding our portfolio of therapies for a number of socially significant diseases for the benefit of Russian patients. So, until 2026, the planned volume of investments will be about 5 billion rubles, which will be distributed between the development of new products and the launch of new production lines,” said Evgenia Shapiro, PSK Pharma’s CEO.