Millions of people who suffer migraines have finally been offered hope of an effective treatment, after trials showed that a new injection could prevent attacks. Three-quarters of those struck by attacks – which can trigger dizziness, nausea and crippling pain – are women.
Although painkillers and other drugs can ease the symptoms, they do not work for everyone and as yet no drug has been found that can actually prevent the attacks. But early trials have now shown that a breakthrough drug can reduce the number of attacks by three quarters in some patients.
Alder BioPharmaceuticals Inc said that in a trial of 600 people, its injection, code-named ALD403, slashed attacks by 75 per cent in a third of patients. The firm, which saw its shares jump 50 per cent when it announced the results, hopes to make the drug available to patients in three years, if further trials go well. It is one of four major pharmaceutical firms racing to be the first to introduce the first drug specifically designed to treat migraines.
Described as one of the few true ‘holy grails’ of medical research, an injection to truly tackle migraines is the being pursued by drugs giants Amgen, Eli Lilly and Teva, who are each competing with Alder to get the first licence for the medication. Alder chief executive Randall Schatzman said he hoped to submit licensing applications for public use in 2019.
‘We’re proposing that patients are dosed four times a year,’ he said. ‘Most other developers are looking at once-a-month dosing.’
Each of the four companies are developing variants of a drug which tackles a protein called calcitonin gene-related peptide (CGRP), which triggers the pain and nausea associated with a migraine. CGRP causes the swelling of blood vessels intertwined with nerve endings on both sides of the head. Researchers have found that monoclonal blood proteins – antibodies specifically engineered to bind to CGRP – were able to ‘mop up’ the chemical, meaning it did not trigger a migraine.
Scientists realised the significance of CGRP in migraines in the 1980s, but earlier trials were abandoned of fears that they caused liver damage. The latest batch of drugs have shown few safety issues, according to the trial results.
Professor Peter Goadsby, trustee of the UK Migraine Trust, said: ‘This is a huge development for migraine sufferers. There is no current specific treatment that has been developed for migraine. The research has now come to a point where we understand the condition enough that we have worked out how to treat it.‘All the studies that have been done are positive, and there has been an almost-embarrassing lack of side effects.
‘For a group of people who have never had a proper treatment, this is fantastic news.’
Professor Goadsby, who is also director of the NIHR King’s Clinical Research Facility in London, said the fact that several companies are pursuing the drug was very welcome. ‘We have four companies charging along to develop this drug, which can only be a good thing. Competition can only push people along and push down prices.’
All four companies are close to or already have completed phase two trials – and are racing to be the first to complete final phase three trials and get a licence for the drugs – with analysts predicting the market could be worth £6billion a year worldwide.
Sean Harper, vice president of Amgen, said: ‘I can think of only a few examples of holy grails in medicine, which have existed for thousands of years, and this is one of them. There’s just no effective preventive therapy for migraine that’s worth taking,’ he told the Financial Times.
Eli Lilly is focusing on cluster headaches, a rarer condition, but one where there are even fewer effective treatments. It reported a significant reduction in the number of ‘migraine days’ reported by patients who took the drug last June. David Ricks, senior vice president of Eli Lilly, said: ‘These results reinforce our confidence in the potential of this medicine to be a significant option for the preventive treatment of debilitating headache disorders like migraine and cluster headache.’
Teva, an Israeli drugs company, reported similar results for its own drug in September. The firm’s vice-president Marcelo Bigal said: ‘These findings constitute an exciting landmark in the development of migraine prevention treatment options.’