Latest news with #EmiratesDrugEstablishment
Dubai Eye
08-07-2025
- Health
- Dubai Eye
UAE first to approve oral therapy for rare autoimmune disorder
The UAE has become the first country in the world to approve an oral therapy for a rare autoimmune disorder. The newly authorised drug, Rilzabrutinib, targets Immune Thrombocytopenia - a condition that affects just a few individuals per 100,000 worldwide. Developed by global pharmaceutical company Sanofi, Rilzabrutinib is the first oral Bruton's tyrosine kinase inhibitor to be approved for this condition. The treatment works by restoring immune system balance and increasing platelet counts, offering patients faster relief and improved quality of life. Clinical studies have demonstrated promising outcomes, with patients reporting substantial improvement in health indicators. Dr. Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, says the approval reflects the UAE's commitment to pioneering advanced therapies and strengthening its role as a regional leader in pharmaceutical innovation. #WamNews — WAM English (@WAMNEWS_ENG) July 8, 2025
TAG 91.1
08-07-2025
- Health
- TAG 91.1
UAE first to approve oral therapy for rare autoimmune disorder
The UAE has become the first country in the world to approve an oral therapy for a rare autoimmune disorder. The newly authorised drug, Rilzabrutinib, targets Immune Thrombocytopenia - a condition that affects just a few individuals per 100,000 worldwide. Developed by global pharmaceutical company Sanofi, Rilzabrutinib is the first oral Bruton's tyrosine kinase inhibitor to be approved for this condition. The treatment works by restoring immune system balance and increasing platelet counts, offering patients faster relief and improved quality of life. Clinical studies have demonstrated promising outcomes, with patients reporting substantial improvement in health indicators. Dr. Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, says the approval reflects the UAE's commitment to pioneering advanced therapies and strengthening its role as a regional leader in pharmaceutical innovation. Emirates Drug Establishment approves world's first oral therapy for immune thrombocytopenia #WamNews — WAM English (@WAMNEWS_ENG) July 8, 2025
Al Etihad
08-07-2025
- Business
- Al Etihad
Emirates Drug Establishment approves world's first oral therapy for immune thrombocytopenia
8 July 2025 14:37 ABU DHABI (WAM) The Emirates Drug Establishment (EDE) has granted official approval for Rilzabrutinib, the first oral Bruton's tyrosine kinase (BTK) inhibitor to be authorised in the country for the treatment of Immune Thrombocytopenia (ITP), a rare autoimmune disorder that affects approximately 2 to 5 individuals per 100,000 people this landmark approval, the UAE becomes the first country in the world to authorise this innovative medication, reflecting the nation's global leadership in accelerating access to advanced treatments and addressing critical medical approval of Rilzabrutinib in the UAE represents a major step forward, offering patients with ITP early access to a pioneering therapeutic solution that contributes to a faster treatment journey and a tangible improvement in quality of decision aligns with the UAE's strategic commitment to ensuring the availability of high-efficacy, globally benchmarked treatments in line with the highest international standards and by global pharmaceutical and healthcare company Sanofi, Rilzabrutinib represents a breakthrough in restoring immune system balance by targeting the underlying cause of increasing platelet counts, the treatment addresses both the symptoms and root causes of the condition. Clinical studies have demonstrated promising outcomes, with patients reporting substantial improvement in health Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, stated, 'The UAE is committed to providing access to the world's latest therapeutic innovations and further promoting its position as a regional hub for pharmaceutical excellence. With Rilzabrutinib getting approved, we take another step further in achieving our strategy aimed at enhancing national pharmaceutical security, implementing advanced treatment protocols, and streamlining regulatory frameworks in collaboration with international partners.'Dr. Al Kaabi emphasised that the milestone demonstrates the effectiveness of the UAE's proactive healthcare policies and flexible regulatory systems in fostering innovation and facilitating patient access to advanced medications.'The Emirates Drug Establishment will spare no effort to accelerate regulatory procedures, and strengthen global partnerships,' she said. 'This further solidifies the UAE's role as a regional centre for pharmaceutical innovation.'She added, 'Granting approval for Rilzabrutinib reaffirms the Establishment's commitment to fast-tracking access to transformative therapies that create significant impact, particularly in the treatment of rare and chronic diseases. EDE will continue to adopt a proactive, innovation-driven approach, fuelled by international collaboration, to ensure that safe, effective therapeutic options are available across the country in accordance with the highest global standards. Our goal is to enhance the UAE's health system preparedness in an era of rapid scientific progress.' For her part, Preeti Futnani, MCO Lead and General Manager, Specialty Care for KSA & Gulf Countries at Sanofi, said, 'We are honoured to collaborate with the Emirates Drug Establishment to bring this groundbreaking treatment to patients in the UAE living with Immune Thrombocytopenia. The approval of Rilzabrutinib demonstrates our shared commitment to placing patients at the centre of our mission and delivering cutting-edge solutions that address some of the most pressing unmet medical needs.'
Zawya
04-05-2025
- Health
- Zawya
EDE strengthens partnerships to ensure pharmaceutical security and support industry growth
Dr. Thani Al Zeyoudi: 'We are striving to achieve strategic integration among stakeholders in the pharmaceutical sector, which is the backbone of our national health security strategy.' Dr. Fatima Al Kaabi: 'We are committed to investing in innovation and technology to build a fully integrated pharmaceutical ecosystem that can meet future demands.' Dr. Al Zeyoudi and EDE members briefed on the latest technologies being utilized in pharmaceutical manufacturing Commending national companies' contributions to 'Make it in the Emirates' initiative and economic growth Exploring avenues for supporting the pharmaceutical sector and enhancing long-term self-sufficiency UAE, Ras Al Khaimah: His Excellency Dr. Thani bin Ahmed Al Zeyoudi, Minister of State for Foreign Trade and Chairman of the Board of Directors of the Emirates Drug Establishment (EDE) visited the Gulf Pharmaceutical Industries (Julphar) in Ras Al Khaimah. His Excellency was accompanied by H.E. Dr. Maha Taysir Barakat, Assistant Minister for Medical Affairs and Life Sciences Ministry of Foreign Affairs, as the Vice Chairman of EDE, H.E. Dr. Amer Ahmad Sharif, CEO of Dubai Academic Health Corporation and President of Mohammed Bin Rashid University of Medicine and Health Sciences (MBRU) and Member of the EDE Board of Directors, H.E. Dr. Fatima Al Kaabi, Director General of EDE, and Ahmed Al Rumaithi, Youth representative on the EDE Board of Directors. During the visit, H.E. Al Zeyoudi along with board members toured Julphar's production facilities, where they were briefed about the company's advanced manufacturing lines and technologies used to produce a wide range of pharmaceutical products, including treatments enhancing patients' quality of life. The visit comes as part of the establishment's commitment to empowering national pharmaceutical manufacturers and strengthening the UAE's pharmaceutical security system. It also aligns with the EDE's objectives to build effective partnerships with local producers, enhance domestic manufacturing capacity, and promote self-sufficiency, reinforcing the UAE's position as a regional and global hub for innovative pharmaceutical development. World-class pharmaceutical ecosystem His Excellency Dr. Thani Al Zeyoudi emphasised that the pharmaceutical sector plays a fundamental role in building a strong, integrated healthcare system in the UAE, commending Julphar for its remarkable achievements and positioning as a leading national example in the industry. He expressed his appreciation for the company's contributions, describing Julphar as one of the UAE's prestigious institutions in the pharmaceutical field. Al Zeyoudi reaffirmed the establishment's keenness to support successful homegrown industrial projects that contribute to realising the country's goals of developing a diversified and sustainable economy. His Excellency also lauded the important role that national companies play in driving the success of the 'Make it in the Emirates' initiative, which is designed to showcase the strength of local products and enhance their competitiveness in international markets. 'Through these visits, we seek to build a strategic collaboration among key players in the pharmaceutical sector,' the minister said. 'Promoting locally manufactured pharmaceutical products is not only a priority within our national health security strategy but also reinforces the leadership's vision to diversify the economic base and institutionalise sustainability and competitiveness across strategic industries.' His Excellency added: 'The establishment has adopted an integrated approach that focuses on strengthening regulatory frameworks, delivering technical support to local manufacturers, driving investment in research and development, and opening new avenues for scientific collaboration with international institutions. Our efforts are all directed toward a single goal: to ensure the availability of safe and effective pharmaceutical products at competitive prices and to develop a national pharmaceutical industry that competes effectively on the global stage.' Empowering national capabilities For her part, Dr. Fatima Al Kaabi stressed that the establishment is committed to strengthening collaboration with national manufacturers such as Julphar, recognising its role as a key partner in advancing the UAE's pharmaceutical security goals. 'Our future plans are not only aimed at enhancing organisational efficiency, and building advanced technological platforms, but also at forging effective partnerships to support the growth and expansion of local pharmaceutical manufacturers,' Al Kaabi said. 'We are also working to adopt world-class pharmaceutical control and quality assurance systems in line with international best practices.' She added: 'We are continuously exploring the use of artificial intelligence to upgrade pharmaceutical research and production while encouraging local companies to expand their export footprint. At the same time, we are keen to build global partnerships that facilitate the transfer of advanced knowledge and expertise to national talent across this vital sector.' EDE Support Meanwhile, Basil Ziadeh, CEO of Julphar, expressed his appreciation for the visit, highlighting its importance in strengthening cooperation between the public and private sectors. 'We are honoured by the visit of His Excellency Dr. Thani Al Zeyoudi and his delegation. This reflects the government's continued support for the pharmaceutical sector. 'At Julphar, we are committed to utilising the latest innovations, investing in national talent, and adopting modern technologies. We will continue to support the country's strategic goals of achieving pharmaceutical self-sufficiency and bolstering the UAE's position as a leading regional manufacturing hub. Make it in the Emirates initiative is truly a source of pride and it will continue to be our guiding light as we pursue sustainable growth and global competitiveness.' The company also expressed its appreciation for the Emirates Drug Establishment's initiative to fast-track the evaluation of national manufacturers' products. This initiative, which includes an integrated and expedited mechanism supported by a wide range of incentives and competitive advantages, will significantly boost the national pharmaceutical industry. It will also enhance its capacity to compete in international markets. The visit featured an interactive dialogue session that explored challenges and opportunities within the pharmaceutical sector. Discussions focused on strengthening public-private sector coordination, enhancing the legislative and regulatory environment, promoting investment in research and development, and supporting innovation initiatives aligned with national strategic objectives.
Hi Dubai
17-04-2025
- Health
- Hi Dubai
UAE Becomes Second Country to Approve Guselkumab for Crohn's Disease Treatment
The Emirates Drug Establishment (EDE) has approved new indications for Guselkumab, marking the UAE as only the second country globally to authorise its use in treating Crohn's disease. This move significantly expands treatment options for patients with chronic inflammatory bowel disorders, particularly those unresponsive to current therapies. Guselkumab has shown strong clinical results in managing symptoms and improving outcomes for individuals living with inflammatory bowel disease. Dr. Fatima Al Kaabi, Director-General of the EDE, said the decision reflects the UAE's proactive healthcare strategy. 'With new indications for Guselkumab being approved, we see the impact of the UAE's forward-looking policies in accelerating access to innovative therapies and enhancing pharmaceutical security,' she stated. The approval stems from a rigorous evaluation of global clinical data, confirming Guselkumab's potential in tackling treatment-resistant Crohn's cases. It also aligns with the UAE's broader goal of ensuring rapid access to cutting-edge medical solutions through precision-driven regulatory processes and global partnerships. 'Our fast-track framework, supported by advanced technologies and strong collaboration with international pharmaceutical companies, has helped streamline reviews without compromising safety or efficacy,' Al Kaabi added. This milestone further underscores the UAE's role as a regional and global leader in healthcare innovation. The EDE's commitment to modernising regulatory systems ensures that patients across the country have timely access to the latest treatments, reinforcing the nation's position as a trusted hub for advanced medical solutions. News Source: Emirates News Agency
