A novel drug for the prevention of episodic migraine has passed a pivotal phase III trial, raising hopes of a new therapy for people whose lives are blighted by frequent headaches.
Co-developed by Novartis and Amgen, AMG 334 (erenumab) inhibits the receptor for calcitonin gene-related peptide (CGRP), a peptide thought to play a key role in the development of migraines. Novartis and Amgen are in a race with Teva, Eli Lilly and Alder Biopharmaceuticals to bring the first CGRP-blocking drug to market.
These drugs that are being developed for people who suffer multiple attacks every month could – if approved – become the first treatment that can prevent migraines with a single injection given every few weeks. Analysts at Credit Suisse have previously suggested that AMG 334 could be launched in 2018 and quickly become a blockbuster with sales in excess of $2.3bn.
The ARISE study enrolled 577 people with episodic migraine – suffering an average of four to 14 migraine days per month. Monthly treatment with AMG 334 over 12 weeks achieved a statistically significant 2.9-day reduction in monthly migraine days, compared to a 1.8 day reduction with placebo.
That result follows an earlier phase II trial in chronic migraine, defined as patients who suffer 15 or more migraine days per month. In that trial, patients with an average of 18 attacks per month saw a 6.6-day reduction with AMG 334 and 4.2 days fewer on placebo.
Novartis and Amgen are also carrying out another phase III trial comparing AMG 334 to placebo over 24 weeks, with results due by the end of the year.
“People who suffer from episodic migraine experience substantial pain, disability and physical impairment, which can significantly disrupt their ability to participate in everyday activities,” said Novartis’ chief medical officer Vasant Narasimhan.
“The positive results from ARISE are especially encouraging because there are currently no treatment options specifically designed for the prevention of migraine.”
Migraine is the most prevalent of all neurological disorders and affects more than 10% of the worldwide population. The World Health Organization lists it as one of the top 10 causes of years lived with disability for men and women.