Hope at last for migraine sufferers: 'Holy grail' monthly jab which halves attacks could be approved by NHS in new year
- Medication, called erenumab, is the first in a new class of drugs?
- It tackles the protein responsible for pain and nausea associated with migraine
- Submitted for medical licence in Europe and US; will be assessed by NHS watchdog NICE in May
- Over 8million Britons - three quarters of them women - suffer migraine attacks
Millions of people are set to benefit from the first new migraine drug in 20 years, a landmark study revealed last night.
The monthly injection, called erenumab, prevents nearly half of migraine attacks for people who have few other treatment options, scientists found.
The medication, developed by UK scientists over the last three decades, has been submitted for a medical licence in Europe and the US and will be assessed by NHS watchdog NICE in May.
More than eight million Britons - three quarters of them women - suffer migraine attacks, which involve dizziness, nausea and headaches.
Millions of people are set to benefit from the first new migraine drug in 20 years, a landmark study revealed last night. (File photo)
Attacks can last anything from four to 72 hours.
The problem affects more people than diabetes, asthma and epilepsy combined - and is the sixth most common cause of disability in the world.
Yet until now there has been no treatment specifically designed to prevent the problem, with patients instead given beta blockers, antidepressants and botox in a bid to stave off the crippling attacks.
Erenumab is the first in a new class of drugs which instead tackles the protein responsible for the pain and nausea associated with a migraine.
The protein - called calcitonin gene-related peptide (CGRP) - causes blood vessels intertwined with nerve endings in the head to swell up.
The pain of migraine
- Migraines are caused by a complex neurological condition which can affect the whole body - causing crippling headaches, nausea, blackouts, vomiting and even paralysis.
- Roughly 8.5million people in Britain suffer from migraines, three quarters of them women, with attacks lasting between four and 72 hours.
- Sufferers experience an average of 13 attacks each year, usually in clusters or episodes of a few days.
- But for about half a million people - those with ‘chronic migraines’ - the attacks come at least every other day.
- Migraines are the sixth most common cause of disability around the world, and are strongly linked to depression and work absenteeism.
- Current drugs include Triptans - which deal with the symptoms but not the cause - but if they are taken too often they actually increase the frequency of attacks.
- Other treatments which ward off attacks are all designed for other conditions - such as botox, epilepsy medicines and beta blockers for heart disease.
- The new drug works in a completely different way - attacking the cause of migraines by stopping a protein which causes blood vessels to swell in the brain.
Erenumab contains an antibody that blocks that process.
Described as one of the few true ‘holy grails’ of medical research, an injection to tackle migraines has been pursued by some of the world’s biggest drugs firms.
Erenumab, which is self-administered into the thigh or stomach with an injection pen, is the first new migraine treatment since Triptans – drugs which ease the symptoms of migraines but not the cause – were developed in 1997.
If it is approved by NICE for NHS use next year, up to half a million patients with the most serious migraines might initially benefit, although this might rise in future.
Study leader Professor Peter Goadsby of King’s College London, who first highlighted the role of CGRP in migraines in 1985, said: ‘This is an incredibly important step forward.
‘It’s the real deal - next year the NHS will be looking at whether to make this available.
‘At the moment people who suffer with migraines are stuck between a rock and a hard place. But they can stop losing hope, because hope is just around the corner.’
The study, published in the prestigious New England Journal of Medicine, involved 955 patients who were given erenumab or a dummy placebo injection for six months.
At the start of the trial, the participants suffered migraines on an average of 8.3 days a month. Within four months, those who took erenumab were experiencing migraines on 3.7 fewer days. Those on placebo saw their migraines come down by only 1.8 days.
The drug was remarkably safe, with patients actually reporting fewer side effects than those taking the placebo.
Simon Evans, chief executive of Migraine Action, said: ‘Migraine is too often trivialised as just a headache when, in reality, it can be a debilitating, chronic condition that can destroy lives.
‘The effects can last for hours – even days in many cases. An option that can prevent migraine and that is well tolerated is therefore sorely needed and we hope that this marks the start of real change in how this condition is treated and perceived.’
Erenumab is made by a partnership between drugs giant Novartis and Amgen.
But hot on their heels are three other firms - Teva, Eli Lilly and Alder - who are developing very similar drugs in a bid to be the first to reach a global market worth an estimated ￡6.5billion a year.
Erenumab is the first to have final phase III results published and the first to submit its findings to the European Medicines Agency and the FDA in the US, but the other three firms are close behind.
Professor Goadsby, who gave away the intellectual property to the drug when he published his first results in the 1990s, said the fact so many companies are competing can only be good for patients.
He is working with all four groups on their trials, and says there is very little to choose between the drugs.
‘From an NHS point of view and a patient point of view, having four companies beating down the door, and potentially beating down the price, is a very good thing,’ he said.
The companies have not yet set a price - and the monoclonal antibodies used to make the drug are very expensive to produce - but Professor Goadsby hopes NICE will recognise the value of the treatment when it assesses it next year.
‘I think NICE will see that there is a group of migraine patients who are sufficiently disabled that this is a way forward.’
He estimates that the drug would initially be assessed for roughly 500,000 patients for whom the existing treatments do not work at all, but said this number might rise in future, especially if the price drops.
Dimitrios Georgiopoulos, chief scientific officer of Novartis UK, said: ‘Migraine is a highly debilitating neurological condition that affects millions of people across the UK - more must be done urgently in order to help reduce the huge personal, societal and economic burden associated with migraine.
‘Erenumab is the most significant breakthrough in this field in 20 years and it is now imperative we continue to work with all parties to make this well-tolerated and effective treatment option for migraine available to those who can benefit from it.’
'Fantastic' news for woman who suffered first migraine aged 11
Tania Dutton (above) was 11 when she first started suffering from migraines
Tania Dutton was 11 when she first started suffering from migraines.
They started out as blistering headaches and slurred speech; by the time she was 13, she had started passing out several times a day.
‘I was seen by epilepsy specialists who said there was nothing on their scans, so it must all be in my head,’ she said.
It was not until Mrs Dutton was 23 that she received a proper diagnosis - a severe form of migraines called basilar migraines, which cause people to lose consciousness.
Her condition is particularly linked to light - so she has to wear special tinted glasses and is banned from driving - and she needs supervision to swim or even take a bath because the reflections on the water could trigger an attack.
With a cocktail of epilepsy drugs, beta blockers and botox Mrs Dutton, now 31, learned to manage her condition - and forged a career teaching oboe and other instruments to school children.
But when she and her husband Dan, a 35-year-old schoolteacher, decided to start a family, she had to come off the drugs because they are harmful in pregnancy.
‘It took me a year to come off the drugs and we are now expecting a baby girl in March,’ she said.
‘But to do that, I have had to give up my job and stay inside the house in case I have an attack. It will all be worth it, but it is not easy.’
Mrs Dutton, who lives in Warwickshire, added: ‘All these drugs are designed for other conditions - and they come with real side effects.
‘So it is fantastic that we are finally getting a drug that is specifically designed for migraines.’
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