Migraine miracle jab 'could be approved by NHS next year

Migraine miracle jab 'could be approved by NHS next year



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.





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.





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.