R-Pharm Group of Companies successfully registered Artlegia (olokizumab), a novel drug for treatment of rheumatoid arthritis in the first country – Russia. The drug is manufactured at the R-Pharm Yaroslavl Plant of Finished Dosage Forms, and has already been sent to a number of Russian health centers.
R-Pharm acquired the worldwide rights for development, manufacturing, and commercialization of olokizumab from UCB, a Belgian based global biopharma company at the Phase II stage of the drug development in 2013. After that, it initiated a large-scale international clinical program of Phase III studies, CREDO. The first study has been completed in 2019. It included 428 patients from 42 study sites in Russia, Belorussia, and Bulgaria and demonstrated the efficacy and safety of olokizumab in combination with methotrexate in patients with moderate to severe rheumatoid arthritis. A single subcutaneous injection once a month proved to be an effective treatment alternative for these patients. The results of CREDO-2 and CREDO-3 international studies, which recruited over 2,000 patients in 18 countries, including the USA, Latin America, and Europe, are expected to follow this summer. Most patients who participated in the Phase III trials decided to continue treatment in the long-term safety and efficacy study CREDO-4 that will continue until 2022.
In 2020, a new clinical study began. It is aimed at investigation of the efficacy and safety of Artlegia in patients with severe COVID-19.
“The appearance of the first original domestic biotechnology drug for the treatment of rheumatoid arthritis in our country is a big step forward in the fight against this severe disabling disease. Olokizumab has a great potential in treatment of patients with autoimmune diseases, and now we are evaluating its efficacy in the treatment of cytokine storm in patients with severe coronavirus infection. We will be ready to present the results very soon,” said Vasily Ignatiev, the General Director of R-Pharm.