As a result of years of collaborative efforts with King Faisal Specialist Hospital and Research Centre (KFSHRC), the Saudi Food and Drug Authority (SFDA) has approved the registration of the first-of-its-kind clinical study (Phase I) of an investigational gene therapy, developed in Saudi Arabia, using Chimeric Antigen Receptor T-cells (CAR T-cells), under the title: “Phase I Study of Chimeric Antigen Receptor (CAR) T-cells in Adult Patients with Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia (ALL), Using a Closed Transduction System.”

The Saudi Food and Drug Authority (SFDA) has approved the registration of Tzield (teplizumab) to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes (T1D).

First Treatment to Delay Type 1 Diabetes

The Saudi Food and Drug Authority (SFDA) has approved a groundbreaking, Saudi-developed medical device for marketing. This innovative tool is designed to improve the safety and efficiency of surgical procedures.

The Saudi Food and Drug Authority (SFDA) has launched an initiative to empower healthcare practitioners and patients by providing access to approved educational and awareness materials that promote the safe use of medications and reduce associated risks. This is achieved through the addition of a “Risk Minimization Measures” page on the dedicated electronic portals for medical personnel, reflecting effective integration between the SFDA and healthcare institutions across Saudi Arabia.

The Saudi Food and Drug Authority (SFDA) has outlined the procedures for obtaining a clearance permit for controlled drugs containing narcotic drugs and psychotropic substances in the possession of travelers arriving in or departing from Saudi Arabia. This reinforces the SFDA’s commitment to facilitating patients’ travel and ensuring a smoother journey while maintaining safety standards.

The Saudi Food and Drug Authority (SFDA) has approved the registration of Elrexfio (Elranatamab) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This Product has been granted an orphan drug designation under the SFDA Orphan Drug Program.

Elranatamab: A Bispecific Antibody

The Saudi Food and Drug Authority (SFDA) has approved the registration of Pyrukynd (Mitapivat) for the treatment of adult patients with alpha- or beta-thalassemia, whether transfusion-dependent and non-transfusion dependent types. This approval represents a regulatory first for this specific medical indication. Pyrukynd had previously been designated by the SFDA as a “Breakthrough Medicine” with the aim to accelerate the availability of innovative therapies.

A Hereditary Blood Disorder