SFDA GrantsBreakthroughDesignation toPrevent and ReduceBleedingEpisodes in Patients with HemophiliaA

The Saudi Food and Drug Authority (SFDA) has granted Novo Nordisk Breakthrough designation to (FREHEMGO), which is indicated as a long-term routine prophylaxis of bleeding episodes in all age groups patients with hemophilia A with or without FVIII inhibitors. 
FREHEMGO contains the active substance “Denecimig” which belongs to a group of protein-based medicines called antibodies. Denecimig binds to two proteins involved in the blood clotting process. 
Registration is Subjected to Full Scientific Evaluation
The SFDA emphasizes that this designation allows FREHEMGO to be submitted and reviewed under the Breakthrough Track, subject to specific regulatory controls and mechanisms. This designation does not constitute a marketing authorization of the drug in Saudi Arabia. A final decision regarding registration will be announced following a full technical and scientific evaluation of the complete registration dossier.
The SFDA Breakthrough Medicine Program Expedites Access to Targeted Treatments
The Program aims to expedite access to innovative and effective treatments for serious diseases where existing therapies may be inadequate. To qualify for this designation, a drug must have completed clinical trials demonstrating promising efficacy and safety, offer a significant therapeutic advantage over current options, target serious or life-threatening conditions, and exhibit a positive benefit-risk balance. Notably, the product should not be registered with any other regulatory authority at the time of application.
Elevating Saudi Arabia’s Global Leadership in the Drug Sector
This designation stands as an extension of the SFDA’s ongoing commitments to fostering global pharmaceutical innovation, enhancing regulatory efficiency, and accelerating access to innovative, high-quality treatments for patients. These efforts directly reflect the Authority’s dedication to elevating Saudi Arabia's regional and international standing within the healthcare and drug sectors, aligning seamlessly with the objectives of Saudi Vision 2030 to foster a vibrant society through an efficient and sustainable healthcare ecosystem.
For further information regarding the Breakthrough Medicines Program, please refer to the official guide available on the SFDA website , Inquiries may be submitted directly to the program’s desk via email at: Designation.Drug@sfda.gov.sa