Novo Nordisk A/S (NYSE:NVO) saw its stock climb 2.1% on Thursday after the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted approval for a daily tablet formulation of Wegovy for weight loss and weight management.
The MHRA authorization represents the first approval in the UK for a GLP-1 receptor agonist in tablet form intended specifically for weight reduction. The oral semaglutide product may be prescribed to adults with a Body Mass Index (BMI) of 30 or above, or to adults who are overweight with a BMI between 27 and 30 provided they have at least one weight-related comorbidity. Use should be in combination with a reduced-calorie diet and increased physical activity.
The approved dosing regimen begins at 1.5 mg once daily. The dose is subsequently increased to 4 mg, then to 9 mg, and finally to 25 mg, with a minimum of one month at each dose level before escalation. For patients already on private treatment with a 2.4 mg semaglutide injection given once weekly, the MHRA said a direct switch to semaglutide 25 mg tablets taken once daily is an available option.
Julian Beach, the MHRA's Executive Director of Healthcare Quality and Access, said the semaglutide tablet met the regulator's stringent criteria for safety, quality and effectiveness. He also emphasized that, consistent with other GLP-1 receptor agonists, the tablet is available only by prescription.
The approved administration instructions are explicit. The tablet must be swallowed whole and taken on an empty stomach after fasting for at least eight hours, accompanied only by a sip of water. Patients should not eat or drink for at least thirty minutes following dosing, since consuming food or drink sooner reduces the drug's absorption.
Although the MHRA has cleared the tablet for use in the UK, it is not currently available through the National Health Service. Any decision about NHS availability will proceed through established routes, including evaluation by the National Institute for Health and Care Excellence, the MHRA said.
The regulatory approval updates the treatment options for weight management in the UK but leaves open questions about wider public access and reimbursement that hinge on subsequent health-technology assessment and procurement processes.