The Emirates Drug Establishment (EDE) has approved Wegovy (semaglutide), an oral once-daily treatment indicated for long-term weight management in adults living with obesity or overweight associated with weight-related medical conditions.
Developed by Novo Nordisk, the treatment belongs to the GLP-1 receptor agonist class and supports long-term weight reduction and weight maintenance when used alongside a reduced-calorie diet and increased physical activity, helping improve health outcomes among eligible patients, said an EDE statement.
Clinical data also showed the treatment's ability to reduce the risk of major adverse cardiovascular events in high-risk patients, including cardiovascular death, heart attacks and strokes.
With this approval, the UAE has become the second country globally to authorise the treatment, in a move reflecting the country’s leadership in adopting advanced therapeutic innovations and enabling early access to them.
Dr Fatma Al Kaabi, Director General of the Emirates Drug Establishment, said: "Approving the oral formulation of Wegovy (semaglutide) reaffirms the establishment’s commitment to promoting the pharmaceutical ecosystem and reinforcing a proactive approach to addressing obesity and overweight challenges, which are among the leading factors associated with chronic diseases, while also supporting the evaluation and approval of innovative therapies in line with internationally recognized scientific standards.”
Al Kaabi added: “This move reflects the UAE’s keenness to adopt the latest pharmaceutical innovations and develop a flexible regulatory environment that ensures patient access to these treatments in accordance with the highest standards, further strengthening treatment outcomes and the overall quality of care.”
The regulatory approval was based on the results of clinical studies demonstrating the treatment’s effectiveness in supporting weight reduction and long-term weight maintenance when combined with a healthy lifestyle, in addition to its role in reducing the risk of major adverse cardiovascular events among at-risk populations.
The approval also cements the UAE’s ongoing efforts to promote health awareness around the importance of early obesity management and reducing associated health complications.
Meanwhile, Venkat Kalyan, General Manager, Novo Nordisk Gulf, said: “Our collaboration with the Emirates Drug Establishment is a testament to our shared commitment to providing innovative and trusted treatment solutions.”
Kalyan added that semaglutide has a well-established safety profile and is widely trusted within the medical community, while its once-daily oral formulation offers greater convenience and supports patient adherence to treatment. -TradeArabia News Service
