UAE fast-tracks approval of Blenrep, pioneering treatment for multiple myeloma

Dubai: The Emirates Drug Establishment (EDE) has announced the registration of Blenrep (Belantamab Mafodotin) as an innovative treatment for patients with multiple myeloma who have relapsed or developed resistance to previous therapies.

With this move, the UAE becomes the third country in the world after the United Kingdom and Japan to approve the drug, marking a strategic milestone that reflects the nation’s proactive approach to fast-tracking access to advanced treatments.

The achievement demonstrates the Establishment’s commitment to building a resilient pharmaceutical system that ensures timely access to effective therapies.

Blenrep represents a major development in the treatment of multiple myeloma, a complex and aggressive form of blood cancer. In 2023, multiple myeloma ranked as the third most common cancer in the UAE. 

The disease affects plasma cells in the bone marrow and is often marked by recurrence or resistance to standard treatments, leaving patients in urgent need of alternative options.

This newly approved therapy offers renewed hope by selectively targeting and eliminating myeloma cells while sparing healthy ones, thereby improving patients’ quality of life and enhancing their chances of recovery.

The drug is the first antibody-drug conjugate (ADC) to target B-cell maturation antigen (BCMA). It is administered in a simplified manner, eliminating the need for complex preparatory procedures or hospitalisation. 

This makes it a practical option across a wide range of healthcare delivery settings in the UAE. The streamlined administration enhances operational efficiency, eases the burden on healthcare resources, and aligns with the Emirates Drug Establishment’s goals of fostering a resilient and adaptable healthcare ecosystem.

Dr. Fatima Al Kaabi, Director General of the Emirates Drug Establishment, emphasised that the rapid registration of Blenrep in the UAE demonstrates the flexibility and efficiency of the Establishment’s regulatory procedures. 

These mechanisms enable the swift evaluation and approval of priority medications, ensuring a timely and effective response to urgent medical cases. She noted that this achievement is part of an institutional framework that leverages advanced technologies and expedited review pathways based on rigorous clinical data, strengthening international confidence in the UAE’s regulatory model.

Al Kaabi further stated that the Emirates Drug Establishment is taking strategic strides to accelerate pharmaceutical innovation and strengthen the integration between regulatory and industrial pathways. We want to enhance the UAE’s capacity to keep pace with global advancements in therapeutic research and facilitate the timely availability of transformative treatments.”

“Through multi-level partnerships with international manufacturers and a future-focused evaluation framework, we are committed to enabling the national healthcare system to respond to urgent medical needs with high-impact therapies that improve patients’ quality of life.”

Al Kaabi highlighted that the Emirates Drug Establishment is committed to positioning the UAE as a regional hub for pharmaceutical innovation by adopting cutting-edge medicines that meet international standards and integrating them into a comprehensive, sustainable pharmaceutical model. 

“This approach strengthens the UAE’s competitiveness on the global regulatory stage and reinforces the Establishment’s commitment to the national vision of building a knowledge-based economy driven by research, development, and regulatory excellence. It also supports efforts to enhance drug safety and broaden the range of available treatment options within the country.”

Meanwhile, Prof. Dr. Mahmoud Marashi, Vice President, Emirates Society of Haematology, and Consultant Haematologist at Mediclinic City Hospital, UAE, said that the registration of Blenrep in the UAE is a strategic milestone aimed at accelerating access to transformative therapies that meaningfully improve patients’ lives.

He emphasised that the drug represents a significant development in the treatment of multiple myeloma, offering renewed hope to a segment of patients through its novel mechanism of action and demonstrated clinical efficacy. “We anticipate that this therapy will play a key role in improving patient outcomes,” he said.