UAE becomes World's Second Country to approve Amgen's Lung Cancer Drug “Lumakras”

June 20, 2021:  The Ministry of Health and Prevention (MoHAP) has recently approved the registration and use of Amgen’s lung cancer drug Lumakras, following the approval of the US Food and Drug Administration (FDA). This step will give lung cancer patients in the UAE early access to this innovative drug in order to help speed up their treatment plan and improve the quality of their life.  

This comes as part of the UAE's keenness to attract and provide innovative medicines that prove effective and efficient and adopt them as treatment protocols, which greatly contributes to the development of the drug system in accordance with the best international practices.
The medicine registration comes in the wake of the application of MoHAP’s innovative mechanism for its accelerators to evaluate and approve the world’s breakthrough drugs in accordance with the Fast Track / Accelerate Process system.

LUMAKRAS is supplied as film-coated tablets for oral use containing 120 mg of sotorasib. The drug is prescribed to adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one previous cancer therapy.

Patient health is a priority
Stressing that patients' health and the quality of their life is a top priority in the UAE, HE Dr. Mohammed Salim Al Olama, MoHAP Under-Secretary and Head of Board of Directors of the Emirates Health Services (EHS), said that the ministry, under the guidance of the wise leadership, is keen to further consolidate the UAE’s leading position in the global pharmaceutical market.

Al Olama underlined that the state's flexible legislative environment has stimulated the global pharmaceutical companies to choose the UAE as a hub for marketing and promoting their new and innovative products, which gives solutions to patients in the country and region.
The approval of this innovative treatment in the UAE to treat lung cancer as the world's second country comes a week after the UAE has approved the emergency use of a highly effective new treatment for COVID-19, becoming the first country in the world to register the drug following the FDA approval. This would help enhance the competitive position of the UAE in establishing quality and safety for therapeutic, healthcare, and pharmaceutical systems in line with the UAE Centennial vision added Al Olama.

UAE, a world-leading country in approving innovative drugs 
 HE Dr. Amin Hussein Al Amiri, the Assistant Undersecretary of the Ministry of Health and Prevention’s Public Health Policy and Licenses pointed out that the ministry is keen to enhance its partnerships with global pharmaceutical companies to make great progress in providing cancer patients with the best means of treatment and healthcare. This would help mitigate the burden on the healthcare system, reduce the number of critical cases, and provide new therapeutic options that contribute to improving the health of patients with lung cancer and reducing their need for medical treatment abroad.
 Al Amiri noted that the approval of the innovative and new medicines in the UAE runs according to a well-thought-out mechanism for drug evaluation and registration, expressing his pleasure with the outstanding outcomes of the national indicators of cancer disease in line with the UAE National Agenda. 

Favored destination
HE Dr. Amin Hussein Al Amiri, commended the keenness of international pharmaceutical companies to provide the UAE with the innovative drug manufacturing files at the same time that they are presented to international bodies such as the FDA and the European Medicines Authority (EMEA) to obtain global accreditation, which includes a review of clinical and bioequivalence studies and stability.

In turn, Dr. Ahmed Mostafa, country manager of Amgen in GCC, said: "We are extremely proud of the UAE's approval for Lumakras drug, making it the second country in the world after the USA that approves and licenses the medicine. Lumakras is a unique and unprecedented treatment for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

We are also very grateful to the Ministry of Health and Prevention for their painstaking efforts, approach, and vision in ensuring the immediate availability of the new and innovative medicines in the UAE, he added.