The Russian biopharmaceutical company PSK Pharma has received a registration certificate for the first Russian-made drug with the active ingredient etanercept under the trade name Rivia. It is a therapy for active juvenile idiopathic polyarthritis, which is an orphan disease. The product is indicated for use in children and adolescents aged 2 to 17 years with insufficient efficacy or intolerance of methotrexate. The company is already producing etanercept in adult dosage, the press service of PSK Pharma reported.
The production will take place in the Dubna SEZ. The drug is going to be presented in the form of a pre-filled 1 ml syringe with 25 mg/ml solution for subcutaneous administration.
Etanercept is included in the list of vital and essential drugs (VED). According to Evgenia Shapiro, General Director of PSK Pharma, this is the ninth drug in the company’s portfolio for the treatment of orphan diseases.
Juvenile idiopathic polyarthritis is a rare, progressive, and potentially life-threatening condition that presents as arthritis of unknown origin lasting more than six weeks in children under 16, provided other joint pathologies are excluded. Delayed treatment can lead to severe arthritis and result in physical disability onset in childhood.
The prevalence of this condition varies globally, ranging from 0,05% to 0,6%. In Russia, the incidence among children under 18 years reaches 62,3 per 100 000, with a mortality rate between 0,5% and 1%.
Earlier, the Ministry of Health registered the first Russian drug based on sapropterin produced by PSK Pharma. It is a synthetic cofactor used in the treatment of phenylketonuria. The VED-listed drug called Sapropterin PSK will be available in 100 mg tablets. In 2024, the Russian public procurement of sapropterin amounted to 3200 packages.
In mid—April, PSK Pharma also received a registration certificate for Ambrisentan PSK, a domestic version of GSK’s orphan drug Volibris for the treatment of pulmonary arterial hypertension. Like the original drug, it is available in tablet form in two dosages: 5 mg and 10 mg.
