The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to MIQNAF (Nafithromycin), developed by Wockhardt Bio AG. This designation is for its use in the treatment of adults with community-acquired bacterial pneumonia (CABP) and other mild to moderate infections such as acute bacterial exacerbations of chronic bronchitis (AECB), acute bacterial sinusitis, and pharyngitis/tonsillitis caused by susceptible pathogens.

As part of its early and comprehensive preparations for the Hajj season 2025, the Saudi Food and Drug Authority (SFDA) has launched a series of field inspection tours across key locations and facilities. The purpose is to assess the state of readiness of the inspection teams and to monitor the implementation of approved plans, with the aim of protecting the health and safety of pilgrims by ensuring the highest standards of food, drug, and medical product safety.

Treatment

The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to Novartis's medication Atrasentan (Vanrafia) , which is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.

A Selective Endothelin (A) Receptor Antagonist

The Saudi Food and Drug Authority (SFDA) has granted breakthrough designation to Sanofi's medication, Fitusiran (Qfitlia), which is indicated for routine prophylaxis to prevent or reduce the frequency 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.

The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to Eli Lilly’s medication, Imlunestrant (Inluriyo), for the treatment of advanced breast cancer. Imlunestrant is being developed as a monotherapy for the treatment of adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer who have previously been treated with an endocrine based regimen.

Imlunestrant: A Selective Estrogen Receptor Inhibitor

Experimental Treatment by mRNA

The Saudi Food and Drug Authority (SFDA) has approved a clinical study registration titled "A Global Phase 1/2 Open-Label Dose-Optimization Study to Evaluate the Safety and Pharmacokinetics of the Biologic Treatment (mRNA-3927) in Participants with Propionic Acidemia." This research will investigate an innovative experimental therapy utilizing messenger RNA (mRNA) technology to address a rare inherited disorder affecting amino acid metabolism.

The Saudi Food and Drug Authority (SFDA) is continuously advancing its regulatory framework and boosting its operational effectiveness. This aligns with the Health Sector Transformation Program, a key pillar of Saudi Vision 2030.

During the Hajj season, the SFDA intensifies its focus on employing technologies to protect pilgrim health and safety by providing top-tier quality control and regulatory services that meet the highest standards.