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The General Pharmaceutical Council (GPhC) has urged health and care professionals to meet relevant regulatory standards amidst the shortage of GLP-1 receptor agonists (GLP-1 RAs). The council said: "We are concerned to hear that people with Type 2 diabetes are experiencing problems accessing GLP-1 receptor agonists (GLP-1 RAs). We know that these are being widely prescribed for weight loss purposes and in some cases prescribed off-label." "We recognise the adverse impact that shortages and supply chain issues can have on patients, the public and wider health and care teams. The Council understands that health and care professionals are using their professional judgement and making decisions in challenging situations, balancing a range of factors such as individual patient needs, wider public health and pressures and limitations on available resources such as medicines shortages or other supply chain issues.

Following a comprehensive review, the Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that current evidence does not support a causal link between Glucagon-Like Peptide-1 (GLP-1) receptor agonists and suicidal behaviour, suicidal ideation, self-injury, or depression. GLP-1 receptor agonists , which contain active ingredients such as exenatide, lixisenatide, liraglutide, dulaglutide, and semaglutide, are commonly used to treat type 2 diabetes and obesity. In July 2023, concerns were raised about the safety of these receptor agonists after post-marketing reports suggested a potential risk of suicidal thoughts and self-harm associated with these medications. As a result, safety reviews were initiated by the Market Authorisation Holders (MAHs), evaluating the UK post-marketing data to assess the potential risks of these drugs. These reviews also examined the risk of depression in the interest of patient safety following reports of these side effects.

Victoza (liraglutide) 6mg/mL pre-filled injection pens, previously used in the treatment of type 2 diabetes mellitus (T2DM), have been out of stock in the UK since August 2023. Novo Nordisk has confirmed to The Pharmaceutical Journal that the product has now been discontinued as part of their broader strategy to consolidate their portfolio. The Danish pharmaceutical company said that they are in close dialogue with the Department of Health and Social Care (DHSC), which is expected to release guidance outlining timelines, alternative treatments, and recommended next steps for healthcare professionals. However, the company clarified that they have no plans to discontinue Saxenda (liraglutide) pre-filled injection pens, though this product has also faced supply restrictions in the UK since shortages began. The DHSC initially announced a national shortage of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), including Victoza, in June 2023. At that time, prescribers were advised to limit use of these drugs for their licensed indications and to avoid initiating new GLP-1 RA therapies for T2DM patients during the shortage.

The Pharmacist's Defence Association (PDA) has raised concerns over the adoption of Digital Clinical Excellence (DiCE) guidelines for online prescribing of GLP-1 receptor agonists for weight management in adults. This follows a clash with expert recommendations commissioned by the General Pharmaceutical Council (GPhC) as the PDA "believes the final guidance conflicts with the expert opinion underpins the GPhC's prosecution strategy towards pharmacist prescribers under investigation." In a recent statement, the PDA highlighted the discrepancy between DiCE's guidance and the expert report employed by the GPhC to prosecute pharmacist prescribers using a questionnaire-based consultation model. This conflict has prompted the PDA to withhold its endorsement of the DiCE guidance as it differs from an expert report commissioned by the GPhC. The PDA's reservations stem from the inherent risks associated with questionnaire-based prescribing.

Medical professionals often prescribe semaglutide to patients who have type 2 diabetes. Along with a balanced diet and regular exercise, it has also shown to be an incredibly efficient weight loss aid for patients. As the active ingredient in well-known brand-name drugs such as Wegovy, Ozempic, and Rybelsus, semaglutide is currently on everybody's lips. But what exactly is semaglutide? Does it really work for weight loss? We'll find an answer for you in this article, and explain the main benefits of using semaglutide for weight loss. What Is Semaglutide? A number of diabetic and weight loss medications, including Wegovy, Ozempic, and Rybelsus, have semaglutide as their active ingredient. This substance is a synthetic form of the hormone glucagon-like peptide-1 (GLP-1), that occurs naturally. Developed by the company Novo Nordisk, semaglutide was first approved by the FDA in 2017 as an injection for the treatment of adult type 2 diabetes (as part of the approval procedure for Ozempic). In 2019, the Food and Drug Administration approved a novel semaglutide form known as Rybelsus. Rybelsus was the first oral GLP-1 receptor agonist for the treatment of type 2 diabetes in the United States.

With Novo Nordisk's patent protection for liraglutide now expired, the UK is set to welcome the first wave of generic weight loss medicines. The British Generic Manufacturers Association (BGMA), the trade body for off-patent medicines, believes these generic versions could "provide could provide much-needed capacity to meet growing demand and alleviate shortages." Liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is primarily used to treat type 2 diabetes and obesity. Novo Nordisk markets liraglutide under the brand names Victoza (for type 2 diabetes and Saxenda (for weight loss). In a statement released on 20 November 2024, the BGMA confirmed that "liraglutide's patent protection was no longer in force, marking the first time generic versions of diabetes and weight loss treatments can be available in the UK." The BGMA anticipates that at least four companies will obtain UK marketing authorisations for generics targeting type 2 diabetes and obesity. However, it remains uncertain how many will launch immediately.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication of semaglutide (Wegovy), authorising its use to reduce the risk of serious heart problems and strokes in adults who are obese or overweight. Semaglutide, a GLP-1 receptor agonist, was previously approved for use in the treatment of obesity and weight management, to be used alongside diet, physical activity and behavioural support. The latest approval establishes it as the first weight loss drug to be prescribed to prevent cardiovascular events, such as cardiovascular death, non-fatal heart attack and non-fatal stroke, in people with established cardiovascular disease and a Body Mass Index (BMI) higher or equal to 27 kg/m2. Novo Nordisk, the manufacturer of Wegovy, received this authorisation on 23 July following compelling evidence from a recent post-approval clinical study involving over 17,600 participants. The study demonstrated that Wegovy, administered at a dose of 2.4 mg once weekly via subcutaneous injection for up to five years, significantly lowers the incidence of major adverse cardiovascular events (MACE) by 20 per cent compared to a placebo.

Amid the rapid rise in semaglutide usage, a study has suggested a potential risk of a rare eye condition associated with the weight loss drug. Semaglutide, a glucagon-like peptide 1 receptor agonist (GLP-1 RA), is available under the brand name Ozempic (by Novo Nordisk) in a lower-dose form for managing type 2 diabetes mellitus (T2DM), and as Wegovy (also by Novo Nordisk) in a higher-dose form for weight management in patients with high body mass indexes. Anecdotal evidence has indicated that semaglutide might be linked to nonarteritic anterior ischemic optic neuropathy (NAION). To investigate this potential connection, researchers in the United States analysed data over a six-year period from nearly 17,000 neuro-ophthalmology patients at Massachusetts Eye and Ear Hospital in Boston, Massachusetts, all of whom had no prior history of NAION.

National Institute of Health and Care Excellence (NICE) has not recommended 'Tirzepatide', also known as Mounjaro, developed by Eli Lilly, in its draft guidance issued on Tuesday (27 June) for treating type 2 diabetes in adults alongside diet and exercise. The independent NICE committee recognised the importance of new treatment options given that fewer than two-thirds of the adults with type 2 diabetes have adequate glucose control when using current treatment options. Evidence submitted to the committee from clinical trials showed the use of tirzepatide at any dose resulted in better glucose control and lower weight compared with semaglutide or insulin therapy. The weight reduction was more pronounced with higher doses of tirzepatide, while the effect on glucose levels seemed less dose-dependent. Similar effects were observed against all GLP-1 receptor agonists in company's network meta-analysis, but this was uncertain. The committee have asked the company to provide more data to address the uncertainties in the clinical evidence, when compared to all relevant alternative treatments.

The MHRA on Wednesday granted a license for Eli Lilly's new Alzheimer's treatment, donanemab, for use in adults with mild cognitive impairment or mild dementia due to Alzheimer's disease. However, the drug will not be available on the NHS, as the National Institute for Health and Care Excellence (NICE) concluded that it "does not currently demonstrate value for the NHS." The health spending watchdog explained that the costs of providing donanemab, including regular infusions and intensive monitoring for serious side effects, outweigh the relatively small benefits it offers to patients, and so it "cannot currently be considered good value for the taxpayer." Helen Knight, director of medicines evaluation at NICE, said: "For NICE to be able to approve a medicine for use in the NHS it must provide additional benefits to patients, and it must also represent a good use of NHS resources and taxpayers' money. Donanemab (also called Kisunla) is a monoclonal antibody drug given by infusion (through a drip in the arm). It targets and reduces beta-amyloid proteins, whose abnormal buildup is associated with Alzheimer's disease.