The Ministry of Health and Prevention announced that the UAE is the second country in the world to approve the registration and use of the drug "Lumakras" for lung cancer treatment, produced by the American company Amgen. This follows its approval by the U.S. Food and Drug Administration (FDA). The significance of this drug registration lies in prioritizing lung cancer patients in the UAE to access this innovative medication, thus expediting treatment plans and improving their quality of life. This aligns with the UAE's global leadership in attracting and providing innovative drugs that have proven effectiveness and efficiency, contributing significantly to the development of the pharmaceutical system according to best global practices.
Following the implementation of an innovative operational acceleration mechanism by the ministry to evaluate and approve pioneering or first-of-its-kind drugs in a fast-tracked pathway, the product "Lumakras" 120 mg containing the active ingredient "sotorasib" was approved. It is a prescription medication used for adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body, cannot be surgically removed, or involves the abnormal "KRAS G12C" gene in patients who have received at least one prior cancer treatment.
Dr. Muhammad Salim Al Olama, Undersecretary of the Ministry of Health and Prevention and Chairman of the Board of the Emirates Health Services Corporation, emphasized that the health of patients and the enhancement of their quality of life are priorities in the UAE. The ministry, under the guidance of the leadership, aims to enhance the UAE's position in the global pharmaceutical market thanks to its flexible regulatory environment, establishing it as a leading destination for global pharmaceutical companies. This has provided a competitive advantage over peers, leading these companies to make the UAE a hub for marketing their innovative products, thereby offering solutions to patients in the country and the region.
He noted that the approval of this innovative lung cancer treatment in the UAE, as the second country globally, comes just a week after the UAE approved the emergency use of a new effective COVID-19 treatment as the first country in the world, following clearance from the U.S. FDA. This further strengthens the country's competitive position and solidifies its global leadership in establishing quality and safety systems for therapeutic and health-related products in line with the UAE Centennial Vision.
Dr. Amin Al-Amiri, Assistant Undersecretary for Health Regulation at the ministry, stated that the UAE is a global leader in approving innovative drugs based on a well-studied mechanism for pharmaceutical evaluation and registration. When it comes to cancer drugs, the ministry is enhancing its partnerships with pharmaceutical production companies to achieve qualitative progress in healthcare related to cancer diseases, reducing pressure on the healthcare system, decreasing the number of critical cases, and providing innovative treatment options to improve the health of lung cancer patients in the UAE, lessening their need to travel abroad for healthcare services. He affirmed the achievement of advanced results in national cancer disease indicators aligning with the national agenda.
He also noted the eagerness of global pharmaceutical companies to provide the UAE with files for innovative drugs, parallel to their submissions to international bodies such as the U.S. FDA and the European Medicines Agency (EMA) for global approval, which includes reviewing clinical studies, bioequivalence studies, and stability studies.
Dr. Ahmad Mustafa, Director of Amgen for the Gulf States, stated: "We are proud of the approval of Lumakras in the UAE, unique and unprecedented for treating patients with advanced non-small cell lung cancer with the KRAS G12C mutation, making the UAE the second country worldwide to allow the use of this drug. We thank the Ministry of Health and Prevention for its ongoing efforts, approach, and vision ensuring the immediate availability of modern and innovative medicines."
