SFDA Grants Promising Drug Status to Novo Nordisk’s Frehemgo for Hemophilia A | iPharmaCenter
- Badari Andukuri
- May 28
- 2 min read
The Saudi Food and Drug Authority (SFDA) has granted Novo Nordisk’s therapy, denecimig, designation as a “promising drug.” The therapy is intended for long-term use to prevent or reduce bleeding episodes in patients with hemophilia A across different age groups, regardless of the presence of factor VIII inhibitors.
Denecimig, a bispecific antibody belonging to a class of protein-based therapies. It works by binding to two key proteins involved in the blood clotting process, thereby helping restore effective clot formation.
The SFDA emphasized that this designation follows a comprehensive scientific review. However, the designation does not constitute full regulatory approval or marketing authorization. Instead, it allows the company to proceed under the Promising Drugs Program, subject to specific regulatory requirements and pathways. A final decision on registration will be made after the completion of the full technical evaluation in accordance with approved regulations.
What is Promising Drug Program in Saudi Arabia? How to qualify for it?
The Promising Drugs Program is designed to accelerate patient access to high-quality therapies and expand treatment options, particularly in cases where existing standard treatments are insufficient. The SFDA noted that drugs included in this program must demonstrate promising efficacy and safety data from clinical studies, especially for serious or life-threatening conditions.
To qualify for the designation, a drug must target a serious condition, offer benefits that outweigh potential risks, provide a meaningful therapeutic advantage over existing treatments, and not be previously registered with any regulatory authority at the time of application.
This designation reflects the SFDA’s ongoing efforts to support pharmaceutical innovation, strengthen the regulatory framework, and improve patient access to advanced therapies. It also underscores Saudi Arabia’s growing role in the global pharmaceutical and healthcare landscape.
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