The Russian Ministry of Health has registered Eltrombopag PSK (eltrombopag olamine), a drug developed by the Russian biopharmaceutical company PSK Pharma. Eltrombopag is used in hematology in patients over the age of 3 with immune thrombocytopenia and severe aplastic anemia. It is included in the list of vital and essential drugs (VED) and will expand the company’s portfolio for patients eligible for subsidized medicine supply. The press service of PSK Pharma informed GxP News that this is the company’s eighth hematological drug.
The company added that the drug will be manufactured at PSK Pharma’s own production facilities within the Dubna SEZ, in the form of film-coated tablets available in 25 mg and 50 mg dosages, in 28 tablet packs.
According to the State Register of Medicines (GRLS), ten eltrombopag-based drugs have been registered in Russia. According to Evgenia Shapiro, General Director of PSK Pharma, the volume of the Russian government procurement market for eltrombopag in 2024 was 42,000 packages.
The original eltrombopag is produced by the Swiss company Novartis, although it was initially developed by the British pharmaceutical company GlaxoSmithKline. Novartis acquired the rights to the drug and launched it in the US market under the trade name Promacta. The drug was approved by the FDA for the treatment of thrombocytopenia in adults in 2008, and then for children in 2015. In Russia, it is registered under the name Revolade.
Aplastic anemia is a rare hematological disorder, with an estimated incidence of 2-3 cases per million people per year. The disease, which can affect people of any age, leads to severe complications like heavy bleeding, infections, and even death, in severe cases.
Immune thrombocytopenia (ITP) is an autoimmune disease where the body’s immune system mistakenly attacks and destroys platelets, leading to a low platelet count (thrombocytopenia). This can result in easy bruising and bleeding.
