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Scientists comment on the Medicines and Healthcare products Regulatory Agency (MHRA) approving the first GLP-1 receptor agonist oral pill.
Dr Simon Cork, Senior Lecturer in Physiology, Anglia Ruskin University, said:
“Oral weight loss drugs are the next generation of anti-obesity medications that are progressing through clinical trials. The approval of oral Wegovy by the MHRA is the first step towards patients receiving access to these drugs, but still needs to go through further regulatory procedures before these medications will be available on the NHS.
“Oral formulations are likely to be more attractive to patients, as they do not require weekly injections, however clinical trials have shown slightly inferior levels of weight loss compared to injectable forms, particularly Mounjaro.
“Because they do not require the manufacture of complex injectable pen systems, this medication is likely to be cheaper than injectable Wegovy. However the active ingredient is still a small peptide, which is somewhat expensive to manufacture.
“This is in contrast to Orforglipron, a recently FDA approved oral GLP-1 receptor agonist for weight loss, whose active ingredient is a small molecule and shows comparable weight loss to oral Wegovy. Because this drug is a small molecule rather than a peptide, it is cheaper to manufacture and therefore likely to retail for less.
“A relatively small scale clinical trial of just over 200 people with obesity demonstrated an average 13% weight loss with oral Wegovy, which is comparable to injectable formulations. Real world results are known to differ from clinical trials, and time will tell how effective these medications are outside of well controlled conditions.
“Nevertheless, the increasing range of medications allow greater choice for patients, which is ultimately in their best interest.”
Prof Naveed Sattar, Professor of Cardiometabolic Medicine/Honorary Consultant, University of Glasgow, said:
“This is great news for people living with obesity – having more options of medications that yield decent weight loss is essential to help tackle obesity – and oral semaglutide (which now has robust trial evidence to support robust weight losses at higher doses) may suit some people better than injections, perhaps men more so than women, as well as some people from differing ethnic groups.”
Dr Marie Spreckley, Prevention of Diabetes and Related Metabolic Disorders in High Risk Groups, University of Cambridge, said:
“The approval is supported by evidence from a large phase 3 clinical trial programme demonstrating clinically meaningful weight loss in adults living with overweight and obesity. For example, in a phase 3 study of oral semaglutide 25 mg, participants lost an average of 13.6% of their body weight over 64 weeks, compared with 2.2% in the placebo group. As with all medicines, however, the benefits need to be considered alongside potential side effects and the practical requirements associated with taking the medication.
“This approval is an important development because it provides the first oral GLP-1 receptor agonist authorised in the UK specifically for weight management. While oral semaglutide is already available in the UK for the treatment of type 2 diabetes, this is the first tablet formulation of a GLP-1 receptor agonist approved specifically for obesity and weight management.
“For some people, an oral formulation may make treatment more acceptable than injectable therapies. However, it is important to recognise that this treatment still requires careful adherence to dosing instructions. The tablet must be taken under fasting conditions, and patients must wait before eating or drinking, which may present practical challenges for some people in everyday life.
“As with other GLP-1 receptor agonists, gastrointestinal side effects such as nausea, diarrhoea, constipation and vomiting are among the most commonly reported adverse events. Patients should be appropriately informed about both the potential benefits and potential side effects when considering treatment.
“Obesity is a chronic, complex condition, and no single intervention is appropriate or sufficient for everyone. Medications such as semaglutide are one treatment option within a broader framework of obesity care that may also include dietary, behavioural and clinical support, depending on individual needs and circumstances.
“The approval of an oral option represents another positive step in the evolution of obesity treatment. The key questions now relate to access, uptake, long-term adherence, and how best to integrate this treatment into routine care pathways to maximise long-term effectiveness and support for people living with obesity.”
https://www.gov.uk/government/news/first-glp-1-tablet-for-weight-loss-approved-in-the-uk
Declared interests
Dr Simon Cork: “No CoI to declare.”
Prof Naveed Sattar: “NS has consulted for and/or received speaker honoraria from Abbott Laboratories, AbbVie, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Carmot Therapeutics, Eli Lilly, Gan & Lee, GlaxoSmithKline, Hanmi Pharmaceuticals, Janssen, Kailera, Mass Medicines, Menarini-Ricerche, Merck Sharp & Dohme, Metsera, Novartis, Novo Nordisk, Pfizer, Regeneron, Roche, Sanofi, UCB Pharma and Verdiva Bio; and received grant support paid to his University from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche. No shares in any medical areas.”
Dr Marie Spreckley: “Dr Marie Spreckley is a Postdoctoral Researcher at IMS Epidemiology, University of Cambridge, researching obesity, nutrition and behavioural weight management. She has no personal financial interests, consultancy roles, advisory positions, speaker fees, stock ownership or honoraria from companies manufacturing incretin-based therapies.”