The Saudi Food and Drug Authority (SFDA) has granted orphan status to the Russian drug Arcerix®, INN goflicept (R-Pharm) for the treatment of idiopathic recurrent pericarditis (IRP). This is the first time that a Russian drug received this designation in Saudi Arabia, the company’s press service told GxP News.
“This drug significantly improves the quality of life for patients with IRP, a severe and disabling disease. “There are patients with confirmed diagnoses in the country, and we are working on an early access program so they can receive effective therapy as soon as possible,” said Mikhail Samsonov, medical director at R-Pharm.
In Saudi Arabia, orphan drug manufacturers benefit from streamlined processes and support from the SFDA. These incentives aim to accelerate the market launch and improve the availability of new effective treatments for rare diseases.
Arcerix (goflikycept), is a hybrid protein designed to bind and neutralize pro-inflammatory cytokines within the IL-1 family. This drug is the first and only one in Russia used for the targeted therapy of IRP. Its effectiveness was confirmed in the COURSE trial conducted in close cooperation with the Federal State Budgetary Institution Almazov NMRC of the Russian Ministry of Health and a number of other cardiology centers.
The Russian Ministry of Health registered the drug in 2024. In the same year, the medicine received orphan status in Russia and was recommended for inclusion in the list of vital and essential drugs. Goflikicept is under patent protection in 59 countries around the world.
Idiopathic recurrent pericarditis is an autoinflammatory disease that has orphan status in Russia, often requiring significant medical intervention. The excessive production of IL-1β and IL-1α, which are pro-inflammatory cytokines of the IL-1 family, is a key driver of the recurrent disease development.
