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MHRA Review: No Evidence Linking GLP-1 Agonists to Suicidal Thoughts - 0 views

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    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.
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UK approves CStone's Sugemalimab for non-small cell lung cancer treatment - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has awarded marketing authorisation to CStone Pharmaceuticals for sugemalimab (Eqjubi) as a first-line treatment for non-small cell lung cancer (NSCLC) in the UK. NSCLC is the most common form of lung cancer, accounting for around 80 to 85 out of 100 cases. Sugemalimab is now approved as a first-line treatment, in combination with platinum-based chemotherapy, for adult patients with metastatic NSCLC who do not have EGFR-sensitive mutations or ALK, ROS1, or RET genomic alterations. This UK approval follows its recent authorisation by the European Commission, marking the second international approval for sugemalimab. CStone's CEO Dr. Jason Yang described the UK's approval as a significant milestone in their global expansion strategy. "Sugemalimab is the first domestic anti-PD-L1 antibody to receive approval outside of China and has already entered the world's second-largest pharmaceutical market, the EU. "Now, with the UK approval, sugemalimab continued to expand its presence in the European market. The long-term survival data, recently presented at this year's ESMO Congress, further confirmed sugemalimab's value in the frontline treatment landscape for metastatic NSCLC," he said.
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Wegovy Approved to Prevent Heart Problems in Obese Adults | UK 2024 - 0 views

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    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.
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