First drug to slow down progress of type 1 diabetes gets approval
Teplizumab has been licensed for use in adults and children aged eight and older so they can live 'normal lives' for longer.
The UK is the first in Europe to approve the drug with experts hailing it as a 'breakthrough moment'.
In trials the drug has shown it can stop the onset of type 1 diabetes by up to three years.
While it has been licensed for use by the Medicines and Healthcare products Regulatory Agency (MHRA), the medicines regulator, a decision on whether it can be used on the NHS is yet to be made.
Eligible patients will be able to access it privately. The National Institute for Health and Care Excellence (Nice) will decide if the drug is cost effective enough to be paid for by the NHS.
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.
The condition 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 can be 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.
One of the first adults to receive the drug in the UK as part of a trial was Hannah Robinson, 36.
The dentist and mother of two discovered during pregnancy she was in the early stages of developing type 1 diabetes and is receiving the treatment at the Royal Devon University Healthcare NHS Foundation Trust.
She said: 'This new drug offers more freedom and the chance to focus on my health before I have to start thinking differently and managing life as somebody needing daily insulin.
'This isn't just about what I eat or monitoring my glucose, it is also about having more control and not feeling defined by my condition. This treatment could potentially pave the way for a future cure for type 1 diabetes, which is incredible. I feel very lucky to be part of this.'
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.'
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.'
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.'
She 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.
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