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

The Saudi Food and Drug Authority (SFDA) has approved the registration of Leqembi (lecanemab) for the treatment of patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease, who carry no copies or only one copy of the apolipoprotein E4 (ApoE4) gene variants. This marks the first Alzheimer’s treatment to be approved in Saudi Arabia.

An Innovative Biologic Therapy Aimed at Slowing Disease Progression

The Saudi Food and Drug Authority (SFDA) has approved the registration of Skyclarys (Omaveloxolone), which was previously designated as an Orphan Drug under the SFDA Orphan Drug Program. The medication is indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older, a rare inherited neurodegenerative disorder that impairs movement and significantly affects patients' quality of life.

Innovative Mechanism of Action

The Saudi Food and Drug Authority (SFDA) has approved the marketing authorization for in-vitro diagnostic medical devices that utilize biotechnology to accurately detect concentrations of antipsychotic medications in the blood. These include Quetiapine, Olanzapine, Aripiprazole, Clozapine, and Risperidone.

Regulatory Approval Based on Comprehensive Scientific Evaluation

The Saudi Food and Drug Authority (SFDA) has announced the suspension of a European pharmaceutical factory's registration. This decisive action follows an inspection, part of the SFDA's external monitoring program, which uncovered critical and fundamental violations of Good Manufacturing Practices (GMP). The suspension highlights the SFDA's commitment to safeguarding public health and ensuring the safety and quality of medicines available in Saudi Arabia.

The Saudi Food and Drug Authority (SFDA) has approved the registration of Winrevair (Sotatercept), which has been designated as an orphan drug under the SFDA Orphan Drug Program, for the treatment of pulmonary arterial hypertension (PAH) in adult patients classified as WHO Functional Class (FC) II to III, with the aim of improving exercise capacity.

Life-threatening Disease