Qfitlia Receives SFDA Registration For Hemophilia A Or B In Saudi Arabia

The Saudi Food and Drug Authority has authorised the registration of Qfitlia, known as Fitusiran, for people with hemophilia A or B aged 12 years and above, whether or not they have factor VIII or IX inhibitors. The treatment is intended to prevent bleeding or cut how often bleeding happens in these patients.

Qfitlia uses a Small Interfering Ribonucleic Acid mechanism to act on the body’s clotting system. It lowers plasma antithrombin levels, which helps increase thrombin generation. This adjustment supports a better balance of hemostasis and leads to fewer bleeding episodes in people living with hemophilia A or B.

The Saudi Food and Drug Authority states that this authorisation is part of efforts to speed up access to new medicines in the Kingdom of Saudi Arabia. Qfitlia had earlier received a designation within the "Breakthrough Medicine Program", designed to fast-track assessment and availability of therapies for patients who still lack suitable treatment options.

Data from clinical studies showed that Qfitlia reduced bleeding more effectively than on-demand treatments used when bleeding occurs. During the follow-up period, researchers recorded an annual drop in bleeding rates of almost 90 percent. These findings suggest strong control of bleeding episodes and better overall management of hemophilia for eligible patients.

Trial results also identified safety issues that require monitoring while using Qfitlia. The most frequent side effects were reactions at the injection site and increased liver function test values. Because of this, patients starting treatment are advised to have liver function checked every month for at least six months, and again after any change in dose.

Researchers reported additional possible risks, including thrombotic events and gallbladder disease, which may appear during treatment and call for clinical supervision. Healthcare professionals are expected to watch for these complications and manage them according to standard medical practice, especially in patients who already have risk factors related to clotting or gallbladder conditions.

The Saudi Food and Drug Authority notes that the approval of Qfitlia fits with wider health goals in the Kingdom. It supports the Health Sector Transformation Program under Saudi Vision 2030, which seeks to raise quality of life and keep the national healthcare system sustainable while broadening the range of treatment choices available to patients with complex conditions.

With inputs from SPA