UAE approves new indications for 'Guselkumab' to treat patients with Crohn's disease

Al Etihad

16-04-2025

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 disease.Guselkumab 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 cases.Following a comprehensive review of clinical data, Guselkumab has shown promising results in alleviating symptoms and improving outcomes for individuals living with inflammatory bowel diseases.This 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 needs.It 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 prices.Dr. 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 said.She 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.