
Drug that slows onset of type 1 diabetes licensed for use in UK-first
Experts hailed the decision by the Medicines and Healthcare Regulatory Agency (MHRA) as a 'breakthrough moment' that represents a 'turning point' in how the condition is treated.
One hundred years ago the discovery of insulin revolutionised diabetes care. Today's news marks a big step forward Ahmed Moussa, Sanofi
About 400,000 people in the UK have type 1 diabetes, a lifelong condition which causes the immune system to attack insulin-producing cells in the pancreas.
Insulin helps the body use sugar for energy, and without this hormone, blood sugar levels can become dangerously high.
Type 1 diabetes needs constant management to keep blood sugar within range, with patients required to take insulin through injections or pumps.
Teplizumab trains the immune system to stop attacking pancreatic cells.
It is taken by an IV drip for a minimum of 30 minutes over 14 consecutive days.
The drug, which is already approved in the US, has been authorised for use by the MHRA to delay the onset of stage three type 1 diabetes in adults and children aged eight or over by an average of three years.
Ahmed Moussa, general manager of general medicines UK and Ireland at Sanofi, which makes teplizumab, said: 'One hundred years ago the discovery of insulin revolutionised diabetes care. Today's news marks a big step forward.'
The UK is the first country in Europe to be granted a licence.
Type 1 diabetes develops gradually in three stages over months or years. Stage three is usually when people start to experience blood sugar problems and are diagnosed with the condition.
According to the MHRA, teplizumab is used in people with stage two type 1 diabetes, which is an earlier stage of the disease during which patients are at a high risk of progressing to stage three.
Parth Narendran, a professor of diabetes medicine at the University of Birmingham and The Queen Elizabeth Hospital Birmingham, said: 'Teplizumab essentially trains the immune system to stop attacking the beta cells in the pancreas, allowing the pancreas to produce insulin without interference.
'This can allow eligible patients to live normal lives, delaying the need for insulin injections and the full weight of the disease's daily management by up to three years. It allows people to prepare for disease progression rather than facing an abrupt emergency presentation.'
Following the decision by the MHRA, the cost-effectiveness of teplizumab will be assessed by NHS spending watchdog the National Institute for Health and Care Excellence (Nice) to determine if it can be rolled out on the health service.
After years of research, clinical trials and drug development, we have an incredible breakthrough Karen Addington, Breakthrough T1D
Karen Addington, chief executive of the charity Breakthrough T1D, said: 'I am personally delighted and welcome the MHRA's approval of teplizumab.
'After years of research, clinical trials and drug development, we have an incredible breakthrough.'
Reacting to the announcement, Dr Elizabeth Robertson, director of research and clinical at Diabetes UK, said: 'Today's landmark licensing of teplizumab in the UK marks a turning point in the treatment of type 1 diabetes.
'For the first time, we have a medicine that targets the root cause of the condition, offering three precious extra years free from the relentless demands of managing type 1 diabetes.'
Dr Robertson added that the 'next steps are critical'.
'To ensure teplizumab reaches everyone who could benefit, we need it to be made available on the NHS, and the rollout of a screening programme to identify those with early-stage type 1 diabetes,' she said.

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


The Independent
an hour ago
- The Independent
Children's supplement recalled over fears it contains prescription-only sleep drug
A health alert has been issued to parents over a brand of children 's magnesium gummies after batches were found to contain a prescription-only drug used to aid sleep. Melatonin, which may cause drowsiness, headaches, dizziness and nausea, was detected in Kids Magnesium Glycinate Gummies made by Nutrition Ignition. The synthetic hormone is not listed on the packaging of the raspberry-flavoured gummies. Health chiefs have ordered the gummies to be removed from sale, working with online retailers to withdraw all listings. The Medicines and Healthcare products Regulatory Agency (MHRA) has warned parents to stop giving them to children and to safely dispose of any left. According to top US research school John Hopkins Medicine, people should not use melatonin if they have and autoimmune disorder, a seizure disorder or depression. It also says melatonin supplements may raise blood sugar. Experts at the agency, who tested two batches of the supplements, found between 1.5 and 1.7mg of melatonin in each gummy. The usual adult dose of prescription melatonin, to help severe sleep problems or to recover from jet lag, is 2mg. If prescribed for children, the recommended starting dose is 1mg but may be increased to up to 5mg a day. The product packaging advised one or two gummies per day, depending on the child's age. MHRA chiefs say advice should be sought from a healthcare professional if a child has any worrying side effects. According to the NHS, melatonin takes up to two hours to work. It is usually recommended for up to 13 weeks, and anyone taking it for a long time might need help to come off it. But the MHRA says lasting harm is not expected when ingesting melatonin at high levels, and the body typically clears it within 12 hours. Anyone who has the gummies at home is advised to store them in a tamper-proof container until they take it to a pharmacy for disposal. The gummies must now be regulated as a medicine. Nutrition Ignition Kids Magnesium Glycinate Gummies were promoted as supporting 'calm, focus and digestion '. Alison Cave, chief safety officer at the MHRA, said: 'Side-effects such as headache, hyperactivity, a feeling of dizziness and abdominal pain have been reported in children when melatonin is prescribed and used for its licensed indications. No serious side- effects were observed in studies in children. 'Anyone who suspects that their child or a child in their care is having a side-effect from this product is advised to stop taking it and speak to a healthcare professional and report it directly to the MHRA Yellow Card scheme.'


ITV News
an hour ago
- ITV News
Parents urged to get rid of branded kids' gummies due to presence of prescription-only sleep drug
Parents and caregivers have been urged to stop giving their children a brand of nutritional gummies after tests revealed the presence of an undeclared prescription-only medicine used to help sleep conditions. Nutrition Ignition Kids Magnesium Glycinate Gummies are designed to help reduce tiredness and improve the immune system, but the Medicines and Healthcare products Regulatory Agency (MHRA) has told parents to dispose of the product over harmful side effects. Magnesium glycinate is a dietary supplement often recommended to help reduce anxiety and improve sleep. The government body carried out tests in two batches of the branded product and found each gummy contained 1.5mg to 1.7mg of melatonin. While melatonin is a hormone that regulates the sleep cycles and is naturally produced by the body, some UK adults and children aged over six may be prescribed a synthetic version to help with sleep disorders such as insomnia. The recommended starting dose for children is 1mg. The MHRA is currently working with online retailers to pull any listings of the product and remove the gummies from sale. It also said the sleep hormone is not listed anywhere on the Nutrition Ignition Kids Magnesium Glycinate Gummies' packaging, yet the product advises a dose of one or two gummies per day. Taking too much melatonin can cause various side effects, including drowsiness, headache, dizziness and nausea. However, the MHRA said there were no serious side effects present in the studies it carried out. Dr Alison Cave, chief safety officer at MHRA, said: 'We advise any parent or caregiver to stop use of this product and safely dispose of it. 'Side effects such as headache, hyperactivity, a feeling of dizziness and abdominal pain have been reported in children when melatonin is prescribed and used for its licensed indications. No serious side effects were observed in studies in children. 'Anyone who suspects that their child, or a child in their care, is having a side effect from this product is advised to stop taking it and speak to a healthcare professional and report it directly to the MHRA Yellow Card scheme.' Nutrition Ignition Kids Magnesium Glycinate Gummies are sold online as a food supplement, but the MHRA has since removed the product from sale and is working closely with online retailers to remove all listings.


The Independent
an hour ago
- The Independent
Parents urged to stop using brand of children's magnesium gummies due to harmful side effects
Parents have been urged to stop giving their children a brand of gummies after testing revealed the presence of an undeclared prescription-only medicine for sleep disorders. Nutrition Ignition Kids Magnesium Glycinate Gummies claims to help reduce tiredness and boost the immune system, but now the Medicines and Healthcare products Regulatory Agency (MHRA) is working with online retailers to remove the product from sale. Magnesium glycinate is a dietary supplement that can help with anxiety and improve sleep. However, tests on two batches of this specific brand showed between 1.5 and 1.7mg of melatonin in each individual gummy. Melatonin, the hormone that helps regulate the sleep-wake cycle, is naturally produced by the body. However, a synthetic version is authorised for use on prescription in the UK for adults and children over the age of six with sleep disorders such as insomnia. If prescribed, the recommended starting dose is 1mg for children. According to the MHRA, melatonin is not listed anywhere on the packaging of Nutrition Ignition Kids Magnesium Glycinate Gummies. The packaging advises a dose of one to two gummies per day. Taking too much melatonin can cause headaches, drowsiness, dizziness and nausea. Dr Alison Cave, chief safety officer at MHRA, said: 'We advise any parent or caregiver to stop use of this product and safely dispose of it. ' Side effects such as headache, hyperactivity, a feeling of dizziness and abdominal pain have been reported in children when melatonin is prescribed and used for its licensed indications. No serious side effects were observed in studies in children. 'Anyone who suspects that their child, or a child in their care, is having a side effect from this product is advised to stop taking it and speak to a healthcare professional and report it directly to the MHRA Yellow Card scheme.' Nutrition Ignition Kids Magnesium Glycinate Gummies are sold online as a food supplement, but the MHRA has now removed the product from sale and is working with online retailers to remove all listings.