Blockbuster ambitions: Amgen/Novartis team lines up more promising PhIII erenumab data for some of the toughest migraine patients
Researchers have found that a long lasting injection of the new drug can prevent the onset of the migraine attacks by blocking the CGRP. On average, study participants experienced 9 migraine headaches per month and used an acute migraine drug to stop an attack 5 times per month.
Erenumab, marketed by global drug company Novartis under the brand name Aimovig, is not yet licensed for use in the UK. Overall, erenumab reduced the average number of migraine headaches by more than 50 percent for almost a third of the patients, as opposed to only 14 percent in the placebo group.
The drug is now under review by the FDA but based on these results, Reuter predicts that it may be available to US patients at some point in 2018, and to European patients not long after.
"Migraine is a serious, chronic neurological disease with a profound and limiting impact on patients' abilities to carry out everyday tasks", said Vas Narasimhan, MD, who is now CEO of Novartis. He's an adjunct neurologist at Lenox Hill Hospital in New York City and wasn't involved in the new trial.
Aimovig (erenumab), developed in partnership with Amgen, is one of a clutch of drugs from the calcitonin gene-related peptide (CGRP) class drugs that are closing in on approval.
This peptide transmits migraine pain signals.
The new study was funded by drug maker Novartis. In the research, the scientists recruited 246 volunteers who were prone to episodic migraines.
Among them, 39 percent had been treated unsuccessfully with two other medications, 38 percent with three medications and 23 percent with four medications.
The erenumab group also experienced fewer days in which they had headaches and fewer days in which they needed drugs to treat headaches.
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Results of a study among patients who previously failed 2-4 preventative migraine treatments (PMT) show that erenumab is effective and safe for the treatment of migraines.
Each participant was given either 140 milligrams of erenumab (injections) or a placebo once a month for a period of three months.
For those on erenumab, there was an average 1.6 times greater reduction in migraine days and a 1.7 times greater reduction in acute medication days compared to those on placebo. The same was true for only 14 percent in the placebo group.
'That reduction in migraine headache frequency can greatly improve a person's quality of life'.
"Our results show that people who thought their migraines were hard to prevent may actually have hope of finding pain relief", said Reuter.
What's the next step?
Study leader Dr Uwe Reuter, from The Charite-University Medicine Berlin in Germany, said: 'The people we included in our study were considered more hard to treat, meaning that up to four other preventative treatments hadn't worked for them.
The study also tested the safety and tolerability of erenumab. While these options have been successful for some, others report no improvement or side effects. "If we are able to figure out which migraine sufferers are most likely to benefit from this treatment, it will also let us provide care more effectively".
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