Wegovy weight loss pill first to get approval in the UK

Scales weight loss
Liudmila Chernetska / iStock / Getty Images Plus via Getty Images

The UK’s first weight loss pill has been approved by the medicines regulator today (11 June) to be used alongside a reduced-calorie diet and increased exercise.

It is expected to be available via private prescription 'within weeks' according to the manufacturer Novo Nordisk.

The once-daily semaglutide (Wegovy) tablet is authorised to treat adults in the UK with obesity who have:

  • A body mass index (BMI) of 30 or above; or
  • A BMI between 27 and 30 and at least one weight-related comorbidity.

The starting dose for the pill is 1.5mg, escalating to 4mg, 9mg, and 25mg with a minimum duration of one month at each dose level, the Medicines and Healthcare products Regulatory Agency (MHRA) has said.

Related Article: Pharmacies prepare for ‘significant public interest’ in weight-loss pills

The agency confirmed that patients who are currently being treated privately with a weekly 2.4mg Wegovy injection can be transitioned straight to daily semaglutide 25mg tablets.

Julian Beach, executive director of healthcare quality and access at the MHRA, said: ‘Having met the MHRA’s rigorous standards of safety, quality and effectiveness, the semaglutide tablet has been approved in the UK for weight loss and weight management.’

Wegovy tablets should be taken whole on an empty stomach after fasting for at least eight hours with a sip of water, the MHRA said.

After taking it, no food or drink should be consumed for at least thirty minutes as this lowers its absorption.

Similarly to weight-loss injections, the most common side effects of the pill are nausea, diarrhoea, constipation and vomiting.

The MHRA said that although this tablet is approved for UK use, it is not currently available via the NHS. Decisions on NHS use will follow established processes, including an evaluation by the National Institute for Health and Care Excellence (NICE).

Novo Nordisk said that the MHRA approval is based on data from the OASIS clinical trial which found that adults with obesity receiving 25mg semaglutide tablets achieved 13.6% weight loss compared to 2.4% with placebo after 64 weeks.

The study included 307 adults with obesity, or who were overweight with at least one weight-related condition.

Related Article: Weight-loss pills will be easier to counterfeit than jabs, MPs hear

General manager at Novo Nordisk UK, Sebnem Avsar Tuna, said: ‘This marks an important milestone for obesity care in the UK. For the first time, people living with obesity have access to a GLP-1 treatment in a daily pill, allowing them the choice and flexibility of oral treatment to support their long-term weight management.’

The MHRA is the third regulatory authority to license the medicine – after the US Food and Drug Administration (FDA) and UAE Emirates Drug Establishment (EDE) – and the first in Europe.

Online pharmacies have already started gearing up for ‘significant public interest’ in the new pill, with Superdrug Online Doctor launching an information register for people who wish to receive updates on the medication.

Dr Clair Grainger, a GP at Superdrug Online Doctor, said: ‘We’re aware that there is a considerable and growing public interest in the evolving landscape of weight management treatments.

Related Article: Daily pill helps people maintain weight loss after stopping injections, trial shows

‘As new options become available, it’s essential that people have access to reliable information from qualified healthcare professionals rather than unregulated sources.’

During a Health and Social Care Select Committee evidence session on food and weight management last week, MPs raised concerns that a weight-loss pill will be easier to counterfeit than an injection and warned that ‘we will have to be ready’.

 

Related Article: Revealed: How ICBs are taking their own approaches to Mounjaro prescribing

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