A higher dose of Wegovy has received approval in the EU, while the timeline for its review and availability in the UAE remains uncertain.
Dubai: European regulators have approved a higher maintenance dose of the weight-loss drug Wegovy, broadening treatment options for obesity patients in the region, while the timeline for its availability in the UAE remains uncertain.
The European Commission has granted final approval for a 7.2 mg once-weekly dose of semaglutide, following a positive scientific opinion from the European Medicines Agency. This decision applies across all EU member states and enables doctors to prescribe a higher dose for patients needing additional weight reduction after completing lower-dose treatment.
The approval represents a major milestone in the rapidly growing global market for pharmaceutical obesity treatments.
UAE Approval Process Still Underway
Novo Nordisk confirmed to Gulf News that discussions with UAE regulators are ongoing, with no timeline yet set for local availability.
“Andreea Plesa, Corporate Affairs Director at Novo Nordisk UAE, stated: ‘Wegovy 7.2 mg is approved in the EU and the UK and pending approval in several other countries. In the US, Novo Nordisk received the Commissioner’s National Priority Voucher and submitted Wegovy 7.2 mg to the Food and Drug Administration in November 2025.’”
Under the expedited programme, the review is expected by the end of the first quarter of 2026. In the UAE, Novo Nordisk is actively engaged with local regulatory authorities and will share updates on future plans at the appropriate time.
Emirates Drug Establishment was approached for comment on the review status, but the regulator had not responded at the time of publication.
Regulatory Pathway Takes Time
Healthcare experts note that European approval is a significant milestone but does not ensure immediate availability in the UAE.
“Any new formulation must undergo a separate regulatory review before it can be marketed or dispensed in the country,” said Dr Rania Alkhani, Pharmacy Manager at International Modern Hospital.
She explained that approval from the European Medicines Agency is generally required before companies can submit applications to UAE authorities such as the Ministry of Health and Prevention or the Dubai Health Authority.
“The process can take several months up to a year, depending on the completeness of the dossier and its alignment with UAE regulatory standards,” she said.
Clinical Trials Show Significant Weight Reduction
The higher-dose approval was based on large clinical trials involving nearly 2,000 participants. In a key study of adults living with obesity, patients receiving the higher dose over approximately 18 months experienced average weight reductions of about one fifth of their body weight.
Researchers also reported that nearly one in three participants achieved weight loss exceeding 25%, with most of the reduction coming from fat mass rather than muscle tissue — a factor considered critical for maintaining metabolic health.
Reported side effects during the trials included nausea, diarrhoea, and vomiting. These were generally mild to moderate in severity and temporary.
Global Demand Continues to Rise
The new approval comes as global demand for medical weight-loss therapies surges, driven by rising obesity rates and growing awareness of related health risks, including diabetes and cardiovascular disease.
Novo Nordisk executives say the expanded dosing range will provide physicians with greater flexibility in tailoring treatment plans.
“This approval is another important step in helping people living with obesity achieve substantial weight loss,” said Emil Kongshøj Larsen, Executive Vice President for International Operations at Novo Nordisk.
“The new dose provides healthcare professionals with even greater flexibility to tailor treatment and support patients in reaching their weight loss and overall health goals.”
The development marks progress in global treatment options for patients in the UAE, though local availability will depend on regulatory review timelines, which typically take several months beyond international approvals.
