Latest news with #Guselkumab
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
Al Etihad
16-04-2025
- Health
- Al Etihad
UAE approves new indications for 'Guselkumab' to treat patients with Crohn's disease
16 Apr 2025 18:21 ABU DHABI (WAM)The Emirates Drug Establishment (EDE) has approved new indications for Guselkumab, making the UAE the second country globally to authorise the treatment for Crohn's is set to improve treatment opportunities for patients across the UAE and the wider region. As a significant addition to the therapeutic options available for chronic inflammatory bowel disorders, the drug has demonstrated efficacy in managing treatment-resistant a comprehensive review of clinical data, Guselkumab has shown promising results in alleviating symptoms and improving outcomes for individuals living with inflammatory bowel approval is part of the UAE's commitment to providing the latest medical treatments and their applications, as well as fostering innovation in healthcare, which allows patients to access advanced treatments that better meet their health opens the door to a novel treatment option for patients suffering from autoimmune disorders, particularly those with Crohn's disease, an inflammatory bowel condition that can be difficult to treat. It will also support the UAE's efforts to fast-track access to innovative treatments, while also strengthening international collaboration in healthcare, and ensuring the sustainable availability of medical products at competitive Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, stressed that the UAE is committed to ensuring the availability of the latest treatment solutions for patients.'With new indications for Guselkumab being approved, we can see the impact of the UAE's proactive policies in strengthening pharmaceutical security and accelerating access to innovative therapies. After carefully reviewing clinical data, we found strong evidence that this treatment is effective for patients who haven't responded to existing options, making it an important step forward in broadening available therapies,' Al Kaabi added, 'The drug approval process at the Emirates Drug Establishment is defined by precision and thoroughness, utilising advanced technologies and streamlined procedures to enable fast, accurate reviews and informed decision-making. This achievement is a testament to our team's dedication and expertise, as well as to our commitment to realising the UAE leadership's vision of positioning the UAE as a top hub for global pharmaceutical companies."Dr. Fatima Al Kaabi highlighted that this achievement is the result of strong, trusted partnerships between the Emirates Drug Establishment and leading global pharmaceutical companies and health authorities. "These collaborations have played a vital role in streamlining regulatory procedures and accelerating access to innovative medicines. They also reaffirm the UAE government's commitment to delivering advanced treatments to the community through a modern, globally competitive healthcare system.'Dr. Al Kaabi further explained that the Establishment has successfully built a comprehensive and forward-looking regulatory framework for pharmaceutical and medical products. This system is underpinned by a robust pharmaceutical security strategy and the Fast Track mechanism. This integrated approach has enabled the expedited introduction of innovative therapies to patients, without compromising safety or efficacy. She concluded by affirming that the establishment will continue to upgrade its regulatory processes to ensure patients have timely access to the best available treatments, with Guselkumab standing out as a clear example of the UAE's capacity to stay ahead of global medical advancements, reinforcing its status as a regional and international hub for advanced healthcare solutions.
