The Saudi Food and Drug Authority (SFDA) has approved the registration of Qfitlia (fitusiran) for the prevention or reduction of bleeding episodes in adult and adolescent patients aged 12 years and older with hemophilia A or B, with or without factor VIII or IX inhibitors.
In a press release issued today, the SFDA stated that the approval underscores its commitment to accelerating access to advanced treatment options within the Kingdom of Saudi Arabia. Qfitlia had previously been granted designation under the Breakthrough Medicine Program, which is designed to fast-track the assessment and availability of innovative therapies for patients with unmet medical needs.
(SFDA)
According to the SFDA, Qfitlia is a novel therapy based on small interfering ribonucleic acid (siRNA) technology. It works by lowering plasma antithrombin levels, enhancing thrombin generation, and rebalancing hemostasis, thereby reducing the frequency of bleeding episodes in patients with hemophilia A or B.
The announcement noted that clinical trial results demonstrated a significant reduction in bleeding episodes compared with on-demand treatment. Data showed an annual reduction in bleeding rates of nearly 90% during the follow-up period, highlighting the therapy’s effectiveness in preventing bleeding and improving disease management.
The most commonly reported adverse effects in clinical trials included injection-site reactions and elevated liver function tests. As a result, patients are advised to undergo monthly liver function monitoring for at least six months after starting treatment or following any dose adjustment. Studies also identified potential risks such as thrombotic events and gallbladder disease, which require ongoing medical supervision.
This approval reflects the SFDA’s ongoing efforts to support innovation in healthcare and broaden therapeutic options for patients. It also aligns with the goals of the Health Sector Transformation Program under Saudi Vision 2030, which seeks to enhance quality of life and ensure the sustainability of the national healthcare system.
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